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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Patras
• Treatments: Prasugrel Hydrochloride

Criteria

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