ST-Segment Elevation Myocardial Infarction
Conditions
Keywords
Korea, Platelet inhibition, Prasugrel, Ticagrelor, ST-segment elevation myocardial infarction
Brief summary
To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
Detailed description
Prasugrel and ticagrelor are recommended in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Both prasugrel and ticagrelor show more rapid and potent antiplatelet effect compared with clopidogrel. However, previous report comparing the efficacy and safety of prasugrel and ticagrelor in patients with STEMI of East Asian ethnicity is lacking. Therefore, the aim of this study is to compare the antiplatelet efficacy and safety using laboratory platelet function tests and clinical outcomes in patients with STEMI treated with either prasugrel or ticagrelor.
Interventions
DRUGPrasugrel 60 mg
Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
Sponsors
Dong-A University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with ST-segment elevation myocardial infarction * Undergoing primary percutaneous coronary intervention * Aged between 20 and 80 years
Exclusion criteria
* Previous administration of any antagonist of the platelet adenosine diphosphate (ADP) P2Y12 receptor (clopidogrel, prasugrel or ticagrelor) * History of stroke or transient ischemic attack * Previous gastrointestinal bleeding within 6 months, bleeding diathesis, platelet count \< 100,000/mm3 or hemoglobin \< 10 g/dl * Chronic oral anticoagulation treatment * Contraindication to the antiplatelet treatment * Severe renal insufficiency (serum creatine\>2.5 mg/dl) * Severe hepatic dysfunction (serum liver enzyme or bilirubin\>3 times normal limit) * Sever chronic obstructive pulmonary disease (COPD) or bradycardia * Body weight \< 50 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With High Platelet Reactivity | 48 hours after loading dose of study drug | Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) \>235 and platelet reactivity index (PRI) \>50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Event | 30 days | Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria. |
| Adverse Drug Reaction | 30 days | Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention. |
| Major Adverse Cardiac and Cerebrovascular Events | 30 days | Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30. |
| Number of Participants With Low Platelet Reactivity | 48 hours after loading dose of study drug | Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) \<85 and platelet reactivity index (PRI)\<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups. |
| Pre-procedure Platelet Reactivity Index (PRI) | Baseline | Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI). |
| Pre-procedure P2Y12 Reaction Units (PRU) | Baseline | Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU). |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prasugrel Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose. | 19 |
| Ticagrelor Patients administer Ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose. | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Prasugrel | Ticagrelor | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 10 | 55 years STANDARD_DEVIATION 11 | 55 years STANDARD_DEVIATION 11 |
| Body Mass Index (BMI) | 25.3 kg/m^2 STANDARD_DEVIATION 2.7 | 24.4 kg/m^2 STANDARD_DEVIATION 2.4 | 24.9 kg/m^2 STANDARD_DEVIATION 2.4 |
| Region of Enrollment Korea, Republic of | 19 participants | 20 participants | 39 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Number of Participants With High Platelet Reactivity
Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) \>235 and platelet reactivity index (PRI) \>50%.
Time frame: 48 hours after loading dose of study drug
Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prasugrel | Number of Participants With High Platelet Reactivity | PRU>235 | 0 participants |
| Prasugrel | Number of Participants With High Platelet Reactivity | VASP-PRI>50% | 0 participants |
| Ticagrelor | Number of Participants With High Platelet Reactivity | PRU>235 | 0 participants |
| Ticagrelor | Number of Participants With High Platelet Reactivity | VASP-PRI>50% | 0 participants |
Secondary
Adverse Drug Reaction
Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.
Time frame: 30 days
Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number, compared with chi-square statistics or Fisher's exact test, as appropriate.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prasugrel | Adverse Drug Reaction | 0 participants |
| Ticagrelor | Adverse Drug Reaction | 0 participants |
Secondary
Bleeding Event
Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.
Time frame: 30 days
Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prasugrel | Bleeding Event | 0 participants |
| Ticagrelor | Bleeding Event | 0 participants |
Secondary
Major Adverse Cardiac and Cerebrovascular Events
Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.
Time frame: 30 days
Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prasugrel | Major Adverse Cardiac and Cerebrovascular Events | 0 participants |
| Ticagrelor | Major Adverse Cardiac and Cerebrovascular Events | 0 participants |
Secondary
Number of Participants With Low Platelet Reactivity
Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) \<85 and platelet reactivity index (PRI)\<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.
Time frame: 48 hours after loading dose of study drug
Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher's exact test, as appropriate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prasugrel | Number of Participants With Low Platelet Reactivity | PRU<85 | 18 participants |
| Prasugrel | Number of Participants With Low Platelet Reactivity | VASP-PRI<16% | 16 participants |
| Ticagrelor | Number of Participants With Low Platelet Reactivity | PRU<85 | 19 participants |
| Ticagrelor | Number of Participants With Low Platelet Reactivity | VASP-PRI<16% | 16 participants |
Secondary
Pre-procedure P2Y12 Reaction Units (PRU)
Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).
Time frame: Baseline
Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prasugrel | Pre-procedure P2Y12 Reaction Units (PRU) | 259 PRU units |
| Ticagrelor | Pre-procedure P2Y12 Reaction Units (PRU) | 261 PRU units |
Secondary
Pre-procedure Platelet Reactivity Index (PRI)
Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).
Time frame: Baseline
Population: Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prasugrel | Pre-procedure Platelet Reactivity Index (PRI) | 51.2 percentage |
| Ticagrelor | Pre-procedure Platelet Reactivity Index (PRI) | 47.5 percentage |