High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

Study Overview
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Brief Summary
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This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.

Official Title
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High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

Conditions
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Platelet Reactivity

Intervention / Treatment
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* Drug: Prasugrel 100mg loading dose
* Drug: Prasugrel 60mg loading dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ST elevation myocardial infarction Pain onset <12 hours Age >18 and <75 years Written informed consent Exclusion Criteria: history of stroke/transient ischemic attack oral anticoagulation hemodynamic instability platelet count <100000/μL hematocrit <30% creatinine clearance <30 ml/min severe hepatic dysfunction active bleeding weight <60 Kg periprocedural IIb/IIIa inhibitor administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prasugrel 100mg loading dose<br>Prasugrel 100mg loading dose | Drug: Prasugrel 100mg loading dose<br> <br> |
| Active Comparator: Prasugrel 60mg loading dose<br> | Drug: Prasugrel 60mg loading dose<br>* Prasugrel 60mg loading dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity in Platelet reactivity units (PRU) at Hour 2 | Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity in platelet reactivity units (PRU)at hour 1 | Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization | 1 hour | 
| Platelet reactivity in platelet reactivity units (PRU)at hour 0.5 | Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization | 0.5 hours | 
| Platelet reactivity in platelet reactivity units (PRU)at hour 4 | Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization | 4 hours | 
| High platelet reactivity rate (208 PRU threshold) at 0.5 hour | High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization | 0.5 hour | 
| High platelet reactivity rate (208 PRU threshold) at 1 hour | High platelet reactivity rate (208 PRU threshold) 1 hour post randomization | 1 hour | 
| High platelet reactivity rate (208 PRU threshold) at 2 hour | High platelet reactivity rate (208 PRU threshold) 2 hours post randomization | 2 hours | 
| High platelet reactivity rate (208 PRU threshold) at 4 hour | High platelet reactivity rate (208 PRU threshold) 4 hours post randomization | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prasugrel, ST elevation myocardial infarction