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

University of Patras

Status and phase: Completed; Phase 3

Conditions: Platelet Reactivity

Treatments: Drug: Prasugrel 100mg loading dose; Drug: Prasugrel 60mg loading dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01835353

PATRASCARDIOLOGY-13

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Prasugrel 100mg loading dose

Experimental group

Description:

Prasugrel 100mg loading dose

Treatment:

Drug: Prasugrel 100mg loading dose

Prasugrel 60mg loading dose

Active Comparator group

Treatment:

Drug: Prasugrel 60mg loading dose