Coronary Artery Disease
Conditions
Keywords
CAD
Brief summary
To demonstrate that patients treated with cangrelor can be directly switched to oral prasugrel and that patients treated with prasugrel can be switched to cangrelor without a significant decrease in the extent of inhibition of platelet aggregation.
Interventions
DRUGCangrelor
Cangrelor IV administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
DRUGPrasugrel
Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion. Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
Sponsors
The Medicines Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. greater than / equal to 18 and less than 75 years of age 2. stable coronary artery disease defined by the following criteria 1. Previous myocardial infarction defined by admission to the hospital with elevation of markers of injury or the presence of pathologic Q waves on at least 2 contiguous electrocardiogram (ECG) leads. OR 2. Previous revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). AND 3. Treatment with aspirin (ASA) 81 mg daily.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. | A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). |
| Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion | A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures. | A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay. |
| Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion | A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay. |
| Bleeding Events in Accordance With the GUSTO Scale | Day 1 through Day 8 | Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria \[The GUSTO Investigators, 1993\]. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Day 8 - Prasugrel (10mg) Dosing (6 Doses) Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. | 6 |
| Day 8 - Prasugrel (10mg) Dosing (5 Doses) Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)
Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Total | Day 8 - Prasugrel (10mg) Dosing (6 Doses) | Day 8 - Prasugrel (10mg) Dosing (5 Doses) |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 5.87 | 62.3 years STANDARD_DEVIATION 6.47 | 67.3 years STANDARD_DEVIATION 4.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 6 Participants | 6 Participants |
| Region of Enrollment United States | 12 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 6 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 | 0 / 3 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
Time frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
Population: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | Prasugrel Reference (6.0h or 5.5 h) | 1.0 % aggregation | Standard Deviation 1 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.25 h | 27 % aggregation | Standard Deviation 20 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.5 h | 56 % aggregation | Standard Deviation 6.7 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.75 h | 64 % aggregation | Standard Deviation 2.1 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 3.0 h | 58 % aggregation | Standard Deviation 14 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 4.0 h | 1.0 % aggregation | Standard Deviation 1.7 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 4.0 h | 10 % aggregation | Standard Deviation 15 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | Prasugrel Reference (6.0h or 5.5 h) | 2.8 % aggregation | Standard Deviation 3.1 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.75 h | 31 % aggregation | Standard Deviation 33 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 3.0 h | 24 % aggregation | Standard Deviation 26 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.25 h | 25 % aggregation | Standard Deviation 15 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.5 h | 42 % aggregation | Standard Deviation 27 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.25 h | 45 % aggregation | Standard Deviation 24 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.5 h | 62 % aggregation | Standard Deviation 3.8 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 4.0 h | 15 % aggregation | Standard Deviation 18 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.75 h | 69 % aggregation | Standard Deviation 4.6 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | Prasugrel Reference (6.0h or 5.5 h) | 5.0 % aggregation | Standard Deviation 6.2 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 3.0 h | 51 % aggregation | Standard Deviation 5.1 |
Primary
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).
Time frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
Population: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | 1.0 h | 0.5 % aggregation | Standard Deviation 0.8 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | 2.0 h | 0.0 % aggregation | Standard Deviation 0 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | 1.0 h | 1.3 % aggregation | Standard Deviation 2 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | 2.0 h | 1.0 % aggregation | Standard Deviation 1.4 |
Secondary
Bleeding Events in Accordance With the GUSTO Scale
Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria \[The GUSTO Investigators, 1993\].
Time frame: Day 1 through Day 8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Bleeding Events in Accordance With the GUSTO Scale | Mild | 1 participants |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Bleeding Events in Accordance With the GUSTO Scale | Life-threatening/Severe | 0 participants |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Bleeding Events in Accordance With the GUSTO Scale | Moderate | 0 participants |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Bleeding Events in Accordance With the GUSTO Scale | Mild | 0 participants |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Bleeding Events in Accordance With the GUSTO Scale | Moderate | 0 participants |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Bleeding Events in Accordance With the GUSTO Scale | Life-threatening/Severe | 0 participants |
Secondary
Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)
A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
Time frame: Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.
Population: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | Prasugrel Reference (6.0h or 5.5h) - PRU | 7.7 platelet reaction units (PRU) | Standard Deviation 12 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.25h - PRU | 91 platelet reaction units (PRU) | Standard Deviation 82 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.5h - PRU | 242 platelet reaction units (PRU) | Standard Deviation 50 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.75h - PRU | 267 platelet reaction units (PRU) | Standard Deviation 25 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 3.0h - PRU | 239 platelet reaction units (PRU) | Standard Deviation 50 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 4.0h - PRU | 20 platelet reaction units (PRU) | Standard Deviation 31 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 4.0h - PRU | 56 platelet reaction units (PRU) | Standard Deviation 68 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | Prasugrel Reference (6.0h or 5.5h) - PRU | 41 platelet reaction units (PRU) | Standard Deviation 42 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.75h - PRU | 134 platelet reaction units (PRU) | Standard Deviation 94 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 3.0h - PRU | 127 platelet reaction units (PRU) | Standard Deviation 124 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.25h - PRU | 82 platelet reaction units (PRU) | Standard Deviation 39 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.5h - PRU | 181 platelet reaction units (PRU) | Standard Deviation 70 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.25h - PRU | 151 platelet reaction units (PRU) | Standard Deviation 77 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.5h - PRU | 269 platelet reaction units (PRU) | Standard Deviation 38 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 4.0h - PRU | 117 platelet reaction units (PRU) | Standard Deviation 77 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 2.75h - PRU | 285 platelet reaction units (PRU) | Standard Deviation 35 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | Prasugrel Reference (6.0h or 5.5h) - PRU | 74 platelet reaction units (PRU) | Standard Deviation 60 |
| Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h | Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint) | 3.0h - PRU | 242 platelet reaction units (PRU) | Standard Deviation 32 |
Secondary
Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone
A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.
Time frame: Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion
Population: Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | 1.0 h - PRU | 6.3 platelet reaction units (PRU) | Standard Deviation 6.6 |
| Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h) | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | 2.0 h - PRU | 4.7 platelet reaction units (PRU) | Standard Deviation 2.6 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | 1.0 h - PRU | 8.3 platelet reaction units (PRU) | Standard Deviation 5.4 |
| Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h | Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone | 2.0 h - PRU | 13 platelet reaction units (PRU) | Standard Deviation 18 |