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 Patras82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Platelet Reactivity

Interventions

Prasugrel 100mg loading dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Platelet reactivity in Platelet reactivity units (PRU) at Hour 2

Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization

Time frame: 2 hours

Secondary Outcomes

Platelet reactivity in platelet reactivity units (PRU)at hour 1

Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization

Time frame: 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

Time frame: 0.5 hours

Platelet reactivity in platelet reactivity units (PRU)at hour 4

Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization

Time frame: 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

Time frame: 0.5 hour

High platelet reactivity rate (208 PRU threshold) at 1 hour

High platelet reactivity rate (208 PRU threshold) 1 hour post randomization

Time frame: 1 hour

High platelet reactivity rate (208 PRU threshold) at 2 hour

High platelet reactivity rate (208 PRU threshold) 2 hours post randomization