Prasugrel and Ticagrelor in ST-segment Elevation Myocardial Infarction

Study Overview
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Brief Summary
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To compare efficacy and safety of prasugrel and ticagrelor in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Detailed Description
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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.

Official Title
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Comparison of Prasugrel and Ticagrelor Antiplatelet Effects in Korean Patients Presenting With ST-segment Elevation Myocardial Infarction

Conditions
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ST-Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Prasugrel 60 mg
* Drug: Ticagrelor 180 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prasugrel 60 mg<br>Prasugrel 60 mg as loading dose and followed by 10 mg/day as maintenance dose | Drug: Prasugrel 60 mg<br>* Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.<br>* Other names: Effient 60 mg;|
| Experimental: Ticagrelor 180 mg<br>Ticagrelor 180 mg as loading dose and followed by 90 mg twice a day as maintenance dose | Drug: Ticagrelor 180 mg<br>* Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.<br>* Other names: Brilinta 180 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | 48 hours after loading dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac and Cerebrovascular Events | Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30. | 30 days | 
| Bleeding Event | Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria. | 30 days | 
| Adverse Drug Reaction | Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention. | 30 days | 
| 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). | Baseline | 
| 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. | 48 hours after loading dose of study drug | 
| 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). | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Korea, Platelet inhibition, Prasugrel, Ticagrelor, ST-segment elevation myocardial infarction