Clinical Study to compare two different doses of prasugrel given before a cardiac non surgical procedure
- Conditions
- Acute Coronary SyndromesMedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-014176-22-LV
- Lead Sponsor
- Eli Lilly
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4100
Inclusion Criteria
NSTEMI with elevated troponin
Scheduled for early coronary angiography and PCI
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 2050
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2050
Exclusion Criteria
STEMI
Cardiogenic shock at time of randomisation
refractory ventricular arrhythmias
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 NSTEMI patients undergoing PCI;Secondary Objective: Safety and net clinical benefit;Primary end point(s): Composite efficacy endpoint of cardiovascular events;Timepoint(s) of evaluation of this end point: The primary efficacy measure is a composite of clinical endpoints committee (CEC)-adjudicated CV death, MI, stroke, UR, or GPIIb/IIIa inhibitor bailout through 7 days from randomization
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 30 days from randomization;Secondary end point(s): To assess net clinical benefit (composite of all-cause death, MI, stroke or all coronary artery bypass graft [CABG] and non-CABG Thrombolysis in Myocardial Infarction [TIMI] major bleeding) through 7 days from randomization. To compare the 2 prasugrel LD regimens in terms of the incidence of the following: • CV death, MI, or stroke through 30 days from randomization • CV death or MI through 30 days from randomization • CV death, MI, or UR through 30 days from randomization • CV death through 30 days from randomization • Definite or probable stent thrombosis according to the Academic Research Consortium criteria through 30 days from randomization • Net clinical benefit (composite of all-cause death, MI, stroke, or all TIMI major bleeding) through 30 days from randomization