A comparison of prasugrel at the time of percutaneous coronary intervention (PCI) or as pretreatment at the time of diagnosis in patients with NOn-ST-elevation myocardial infarction(NSTEMI): the ACCOAST study - ACCOAST Study
- Conditions
- Acute Coronary SyndromeMedDRA version: 9.1Level: LLTClassification code 10051592
- Registration Number
- EUCTR2009-014176-22-IT
- Lead Sponsor
- Eli Lilly & Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4100
Subjects aged 18 years and above presenting with NSTEMI with elevated troponin (≥1.5 times the upper limit of normal [ULN]) who are scheduled for coronary angiography/PCI ≥2 and <24 hours from planned randomization. If necessary due to timing constraints, coronary angiography/PCI may be scheduled the next day with the intention to perform coronary angiography/PCI within 24 hours but definitely no later than 48 hours from randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
STEMI Cardiogenic shock at time of randomization refractory ventricular arrhytmias congestive heart failure cardiac arrest prior TIA or stroke Active pathological bleeding Severe hepatic impairment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Reduction in cardiovascular events in NSTEMI patients undergoing PCI;Secondary Objective: Safety and net clinical benefit;Primary end point(s): The primary endpoint is a composite of CV death, MI, stroke, UR, or GPIIb/IIIa inhibitor bailout through 7 days from randomization.
- Secondary Outcome Measures
Name Time Method