A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

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

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Daiichi Sankyo Co., Ltd.
• Treatments: Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin

• Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization

• Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels

• May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel

• Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital

Exclusion Criteria:

• Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization

• Have cardiogenic shock

• Have refractory ventricular arrhythmias

• Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)

• Have had cardiac arrest within 1 week of entry or randomization into the study