Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, CAD, heart attack, stable angina, Stable coronary artery disease
Brief summary
The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.
Interventions
Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD)
DRUGClopidogrel (over encapsulated) capsule
Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD)
DRUGAspirin Tablets
Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented stable Coronary Artery Disease (stable angina, previous MI history, previous history of revascularization); * Females of child bearing potential must have a negative pregnancy test prior to receiving study drug and be willing to use a hormonal contraceptive in addition to double barrier contraception
Exclusion criteria
* History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or Coronary Artery Bypass Graft (CABG)) * History of liver or kidney disease * Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high blood pressure, low platelet count, recent major trauma * History of intolerance or allergy to Aspirin or clopidogrel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose | At 2 hours after first dose of study drug | IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug | 4 to 72 Hours after last dose of study drug | IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose | 1 hour after first dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Cardiopulmonary Parameters at Post 6-week Treatment: FEV1 | 6-week post treatment | FEV1 is measured by Spirometry, the unit is Liter. |
| Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose | 4 hours after first dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose | 8 hours after first dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose | 24 hours after first dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose | 0 hour before last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose | 2 hours after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose | 4 hours after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose | 8 hours after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose | 24 hours after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose | 48 hours after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose | 72 hours after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose | 120 hours - Day 5 after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose | 168 hours - Day 7 after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose | 240 hours - Day 10 after last dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
| Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC) | Baseline | FVC is measured by Spirometry, the unit is Liter. |
| Cardiopulmonary Parameters at Post 6-week Treatment: FVC | 6-week post treatment | FVC is measured by Spirometry, the unit is Liter. |
| Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio) | Baseline | FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio. |
| Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio | 6-week post treatment | FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio. |
| Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75) | Baseline | FEF25-75 is measured by Spirometry, the unit is Liter/Second. |
| Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75 | 6-week post treatment | FEF25-75 is measured by Spirometry, the unit is Liter/Second. |
| Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC) | Baseline | FRC is measured by Body Box Plethysmography, the unit is Liter. |
| Cardiopulmonary Parameters Post 6-week Treatment: FRC | 6-week post treatment | FRC is measured by Body Box Plethysmography, the unit is Liter. |
| Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC) | Baseline | TLC is measured by Body Box Plethysmography, the unit is Liter. |
| Cardiopulmonary Parameters Post 6-week Treatment: TLC | 6-week post treatment | TLC is measured by Body Box Plethysmography, the unit is Liter. |
| Cardiopulmonary Parameters at Baseline: Residual Volume (RV) | Baseline | RV is measured by Body Box Plethysmography, the unit is Liter. |
| Cardiopulmonary Parameters Post 6-week Treatment: RV | 6-week post treatment | RV is measured by Body Box Plethysmography, the unit is Liter. |
| Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE) | Baseline | VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute |
| Cardiopulmonary Parameters Post 6-week Treatment: VE | 6-week post treatment | VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute |
| Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR) | Baseline | RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute. |
| Cardiopulmonary Parameters Post 6-week Treatment: RR | 6-week post treatment | RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute. |
| Cardiopulmonary Parameters at Baseline: Tidal Volume (VT) | Baseline | VT is measured by Body Box Plethysmography, the unit is Liter/Minute. |
| Cardiopulmonary Parameters Post 6-week Treatment: VT | 6-week post treatment | VT is measured by Body Box Plethysmography, the unit is Liter/Minute. |
| Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB) | Baseline | DLCOSB is measured by Body Box Plethysmography, the unit is Percent. |
| Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB | 6-week post treatment | DLCOSB is measured by Body Box Plethysmography, the unit is Percent. |
| Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF) | Baseline | EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle. |
| Cardiopulmonary Parameters Post 6-week Treatment: EF | 6-week post treatment | EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle. |
| Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1) | Baseline | FEV1 is measured by Spirometry, the unit is Liter. |
| Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP | 6-week post treatment | NT-proBNP is measured by clinical lab, the unit is pg/mL. |
| Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2) | Baseline | SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin. |
| Cardiopulmonary Parameters Post 6-week Treatment: SpO2 | 6-week post treatment | SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin. |
| Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | Baseline | NT-proBNP is measured by clinical lab, the unit is pg/mL. |
| Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose | 0.5 hours after first dose | IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ticagrelor Ticagrelor 180 mg loading dose followed by 90 mg bd, plus Clopidogrel placebo loading and od maintenance doses | 57 |
| Clopidogrel Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses | 54 |
| Placebo Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses | 12 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 | 1 |
| Overall Study | Incorrect Enrolment | 1 | 1 | 0 |
| Overall Study | Prior commitment medication | 0 | 1 | 0 |
| Overall Study | Severe non-compliance to protocol | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Ticagrelor | Clopidogrel | Placebo | Total |
|---|---|---|---|---|
| Age Continuous | 62.2 Year STANDARD_DEVIATION 9.1 | 65.4 Year STANDARD_DEVIATION 7.98 | 63.9 Year STANDARD_DEVIATION 8.32 | 63.8 Year STANDARD_DEVIATION 8.62 |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 2 Participants | 30 Participants |
| Sex: Female, Male Male | 43 Participants | 40 Participants | 10 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 57 | 22 / 54 | 7 / 12 |
| serious Total, serious adverse events | 0 / 57 | 0 / 54 | 0 / 12 |
Outcome results
Primary
Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: At 2 hours after first dose of study drug
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose | 93.15 Percentage |
| Clopidogrel | Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose | 31.05 Percentage |
Primary
Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug
IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.
Time frame: 4 to 72 Hours after last dose of study drug
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug | -1.037 Percentage/Hour | Standard Error 0.076 |
| Clopidogrel | Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug | -0.482 Percentage/Hour | Standard Error 0.055 |
Secondary
Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)
SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2) | 96.59 Percent | Standard Deviation 1.57 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2) | 96.78 Percent | Standard Deviation 1.949 |
| Placebo | Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2) | 97.58 Percent | Standard Deviation 1.24 |
Secondary
Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)
EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF) | 57.96 Percent | Standard Deviation 9.302 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF) | 61.91 Percent | Standard Deviation 7.624 |
| Placebo | Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF) | 59.92 Percent | Standard Deviation 10.013 |
Secondary
Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is measured by Spirometry, the unit is Liter.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1) | 2.79 Liter | Standard Deviation 0.725 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1) | 2.71 Liter | Standard Deviation 0.791 |
| Placebo | Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1) | 2.94 Liter | Standard Deviation 0.654 |
Secondary
Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)
FVC is measured by Spirometry, the unit is Liter.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC) | 3.72 Liter | Standard Deviation 0.903 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC) | 3.73 Liter | Standard Deviation 1.082 |
| Placebo | Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC) | 4.03 Liter | Standard Deviation 0.858 |
Secondary
Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)
FRC is measured by Body Box Plethysmography, the unit is Liter.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC) | 2.79 Liter | Standard Deviation 0.827 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC) | 2.89 Liter | Standard Deviation 0.876 |
| Placebo | Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC) | 2.91 Liter | Standard Deviation 0.679 |
Secondary
Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75) | 2.88 Liter/second | Standard Deviation 1.251 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75) | 2.70 Liter/second | Standard Deviation 1.208 |
| Placebo | Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75) | 2.50 Liter/second | Standard Deviation 1.243 |
Secondary
Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE) | 12.92 Liter/minute | Standard Deviation 3.95 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE) | 12.17 Liter/minute | Standard Deviation 3.552 |
| Placebo | Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE) | 12.06 Liter/minute | Standard Deviation 4.054 |
Secondary
Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | 163.34 pg/ml | Standard Deviation 184.298 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | 185.98 pg/ml | Standard Deviation 227.141 |
| Placebo | Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | 145.41 pg/ml | Standard Deviation 144.522 |
Secondary
Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio) | 75.01 Ratio | Standard Deviation 7.049 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio) | 73.04 Ratio | Standard Deviation 6.764 |
| Placebo | Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio) | 73.13 Ratio | Standard Deviation 7.226 |
Secondary
Cardiopulmonary Parameters at Baseline: Residual Volume (RV)
RV is measured by Body Box Plethysmography, the unit is Liter.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Residual Volume (RV) | 1.94 Liter | Standard Deviation 0.78 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Residual Volume (RV) | 2.01 Liter | Standard Deviation 0.643 |
| Placebo | Cardiopulmonary Parameters at Baseline: Residual Volume (RV) | 1.91 Liter | Standard Deviation 0.363 |
Secondary
Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR) | 14.79 Breaths/minute | Standard Deviation 2.433 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR) | 14.15 Breaths/minute | Standard Deviation 2.743 |
| Placebo | Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR) | 15.5 Breaths/minute | Standard Deviation 1.977 |
Secondary
Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB) | 17.00 Percent | Standard Deviation 8.673 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB) | 17.29 Percent | Standard Deviation 10.891 |
| Placebo | Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB) | 15.83 Percent | Standard Deviation 6.013 |
Secondary
Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Tidal Volume (VT) | 0.96 Liters/minute | Standard Deviation 0.326 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Tidal Volume (VT) | 0.89 Liters/minute | Standard Deviation 0.322 |
| Placebo | Cardiopulmonary Parameters at Baseline: Tidal Volume (VT) | 0.89 Liters/minute | Standard Deviation 0.273 |
Secondary
Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)
TLC is measured by Body Box Plethysmography, the unit is Liter.
Time frame: Baseline
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 1 baseline data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC) | 5.78 Liter | Standard Deviation 1.299 |
| Clopidogrel | Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC) | 5.83 Liter | Standard Deviation 1.401 |
| Placebo | Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC) | 6.10 Liter | Standard Deviation 1.037 |
Secondary
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1
FEV1 is measured by Spirometry, the unit is Liter.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Post 6-week Treatment: FEV1 | 2.77 Liter | Standard Deviation 0.712 |
| Clopidogrel | Cardiopulmonary Parameters at Post 6-week Treatment: FEV1 | 2.74 Liter | Standard Deviation 0.751 |
| Placebo | Cardiopulmonary Parameters at Post 6-week Treatment: FEV1 | 2.95 Liter | Standard Deviation 0.727 |
Secondary
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio | 74.71 Ratio | Standard Deviation 5.694 |
| Clopidogrel | Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio | 72.84 Ratio | Standard Deviation 6.371 |
| Placebo | Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio | 74.27 Ratio | Standard Deviation 7.836 |
Secondary
Cardiopulmonary Parameters at Post 6-week Treatment: FVC
FVC is measured by Spirometry, the unit is Liter.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters at Post 6-week Treatment: FVC | 3.70 Liter | Standard Deviation 0.933 |
| Clopidogrel | Cardiopulmonary Parameters at Post 6-week Treatment: FVC | 3.78 Liter | Standard Deviation 1.029 |
| Placebo | Cardiopulmonary Parameters at Post 6-week Treatment: FVC | 3.98 Liter | Standard Deviation 0.89 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB | 16.38 Percent | Standard Deviation 8.09 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB | 16.53 Percent | Standard Deviation 8.286 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB | 16.09 Percent | Standard Deviation 7.19 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: EF
EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: EF | 60.70 Percent | Standard Deviation 8.43 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: EF | 62.38 Percent | Standard Deviation 7.096 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: EF | 60.73 Percent | Standard Deviation 9.665 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75 | 2.77 Liter/second | Standard Deviation 1.289 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75 | 2.67 Liter/second | Standard Deviation 1.156 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75 | 2.91 Liter/second | Standard Deviation 1.375 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: FRC
FRC is measured by Body Box Plethysmography, the unit is Liter.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: FRC | 2.73 Liter | Standard Deviation 0.723 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: FRC | 2.79 Liter | Standard Deviation 0.857 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: FRC | 2.75 Liter | Standard Deviation 1 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP | 139.88 pg/ml | Standard Deviation 170.347 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP | 214.43 pg/ml | Standard Deviation 313.429 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP | 140.68 pg/ml | Standard Deviation 145.003 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: RR
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: RR | 15.21 Breaths/minute | Standard Deviation 2.817 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: RR | 15.10 Breaths/minute | Standard Deviation 2.303 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: RR | 14.91 Breaths/minute | Standard Deviation 0.944 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: RV
RV is measured by Body Box Plethysmography, the unit is Liter.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: RV | 1.88 Liter | Standard Deviation 0.621 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: RV | 1.97 Liter | Standard Deviation 0.559 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: RV | 1.90 Liter | Standard Deviation 0.751 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: SpO2
SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: SpO2 | 97.73 Percentage | Standard Deviation 1.239 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: SpO2 | 97.35 Percentage | Standard Deviation 1.262 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: SpO2 | 98.56 Percentage | Standard Deviation 1.014 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: TLC
TLC is measured by Body Box Plethysmography, the unit is Liter.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: TLC | 5.70 Liter | Standard Deviation 1.182 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: TLC | 5.85 Liter | Standard Deviation 1.396 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: TLC | 5.96 Liter | Standard Deviation 1.422 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: VE
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: VE | 13.69 Liter/minute | Standard Deviation 3.582 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: VE | 13.14 Liter/minute | Standard Deviation 5.515 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: VE | 11.45 Liter/minute | Standard Deviation 3.54 |
Secondary
Cardiopulmonary Parameters Post 6-week Treatment: VT
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Time frame: 6-week post treatment
Population: Safety analysis set: included all patients who received at least 1 dose of study drug and contribute to the week 6 post treatment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ticagrelor | Cardiopulmonary Parameters Post 6-week Treatment: VT | 0.92 Liters/minute | Standard Deviation 0.264 |
| Clopidogrel | Cardiopulmonary Parameters Post 6-week Treatment: VT | 0.93 Liters/minute | Standard Deviation 0.393 |
| Placebo | Cardiopulmonary Parameters Post 6-week Treatment: VT | 0.83 Liters/minute | Standard Deviation 0.329 |
Secondary
Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 0.5 hours after first dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose | 45.39 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose | 4.71 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 0 hour before last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose | 74.53 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose | 51.75 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 120 hours - Day 5 after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose | 0.0 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose | 21.15 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 168 hours - Day 7 after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose | 0.0 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose | 6.32 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 1 hour after first dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose | 86.71 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose | 15.83 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 240 hours - Day 10 after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose | 1.64 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose | 0.98 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 24 hours after first dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose | 87.29 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose | 49.64 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 24 hours after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose | 55.18 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose | 53.91 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 2 hours after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose | 91.49 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose | 62.96 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 48 hours after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose | 30.94 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose | 45.79 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 4 hours after first dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose | 98.39 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose | 40.87 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 4 hours after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose | 96.10 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose | 61.80 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 72 hours after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose | 11.76 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose | 21.09 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 8 hours after first dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose | 96.99 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose | 46.90 Percentage |
Secondary
Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 8 hours after last dose
Population: Intent-to-treat analysis set: included patients who were randomised to a treatment group, received at least one dose of study drug, and contributed post baseline data.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ticagrelor | Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose | 88.31 Percentage |
| Clopidogrel | Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose | 61.31 Percentage |