A comparison of prasugrel at the time of percutaneous coronary intervention or as pretreatment at the time of diagnosis in patients with non-ST-segment elevation myocardial infarction: design and rationale for the ACCOAST study.

Abstract

BACKGROUND:

The precise risk/benefit of thienopyridine pretreatment and the optimal dosage and timing of a thienopyridine loading dose (LD) for patients presenting with non-ST-segment elevation (NSTE) acute coronary syndromes are still being debated. Prasugrel, a novel thienopyridine, is an appropriate drug to address this issue as it provides predictably high and rapid inhibition of platelet aggregation.

STUDY DESIGN:

ACCOAST is a phase 3, multicenter, parallel-group, double-blind, and event-driven study designed to compare 2 prasugrel LD schedules in patients with NSTE myocardial infarction who are scheduled for coronary angiography/percutaneous coronary intervention (PCI). Approximately 4,100 patients will be randomly assigned to an initial LD of 30 mg of prasugrel after the diagnosis followed by coronary angiography with an additional dose of 30 mg of prasugrel given at the time of PCI (pretreatment) or an LD of 60 mg of prasugrel given to patients undergoing PCI at the time of the procedure (non-pretreatment). All patients undergoing PCI will receive 5 or 10 mg of prasugrel daily. The primary objective is to test the hypothesis that prasugrel pretreatment is superior to prasugrel non-pretreatment as measured by a reduction in the composite end point of cardiovascular death, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa inhibitor bailout through 7 days from randomization. Key safety end points include TIMI (Thrombolysis In Myocardial Infarction) major and minor bleeding risks.

CONCLUSIONS:

The ACCOAST study will provide important evidence with regard to the benefits and risks of prasugrel pretreatment compared with administration of prasugrel at the time of PCI in patients with NSTE myocardial infarction.

• Authors: Gilles Montalescot, Leonardo Bolognese, Dariusz Dudek, Patrick Goldstein, Christian Hamm, Jean-Francois Tanguay, Jur ten Berg, Petr Widimsky, Junxiang Luo, Debra L Miller, Jochen Goedicke
• Journal: American heart journal (Am Heart J) Vol. 161 Issue 4 Pg. 650-656.e1 (Apr 2011) ISSN: 1097-6744 [Electronic] United States
• PMID: 21473962 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2011 Mosby, Inc. All rights reserved.

Chemical References

• Piperazines
• Purinergic P2Y Receptor Antagonists
• Thiophenes
• Prasugrel Hydrochloride

Topics

• Acute Coronary Syndrome (therapy)
• Angioplasty, Balloon, Coronary
• Double-Blind Method
• Electrocardiography
• Female
• Humans
• Male
• Myocardial Infarction (therapy)
• Piperazines (therapeutic use)
• Prasugrel Hydrochloride
• Purinergic P2Y Receptor Antagonists (therapeutic use)
• Thiophenes (therapeutic use)
• Time Factors
• Treatment Outcome