High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
- Conditions
- Platelet Reactivity
- Interventions
- Registration Number
- NCT01835353
- Lead Sponsor
- University of Patras
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- ST elevation myocardial infarction
- Pain onset <12 hours
- Age >18 and <75 years
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prasugrel 100mg loading dose Prasugrel 100mg loading dose Prasugrel 100mg loading dose Prasugrel 60mg loading dose Prasugrel 60mg loading dose -
- Primary Outcome Measures
Name Time Method Platelet reactivity in Platelet reactivity units (PRU) at Hour 2 2 hours Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization
- Secondary Outcome Measures
Name Time Method High platelet reactivity rate (208 PRU threshold) at 0.5 hour 0.5 hour High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization
High platelet reactivity rate (208 PRU threshold) at 1 hour 1 hour High platelet reactivity rate (208 PRU threshold) 1 hour post randomization
High platelet reactivity rate (208 PRU threshold) at 4 hour 4 hours High platelet reactivity rate (208 PRU threshold) 4 hours post randomization
Platelet reactivity in platelet reactivity units (PRU)at hour 1 1 hour Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization
Platelet reactivity in platelet reactivity units (PRU)at hour 0.5 0.5 hours Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization
Platelet reactivity in platelet reactivity units (PRU)at hour 4 4 hours Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization
High platelet reactivity rate (208 PRU threshold) at 2 hour 2 hours High platelet reactivity rate (208 PRU threshold) 2 hours post randomization
Trial Locations
- Locations (1)
Dimitrios Alexopoulos
🇬🇷Patras, Achaia, Greece