A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
NCT00699998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9326
Last updated 2013-05-07
Summary
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).
Conditions
- Acute Coronary Syndrome
Interventions
- DRUG
-
Clopidogrel
300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study
- DRUG
-
Prasugrel
30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study
- DRUG
-
Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study
Sponsors & Collaborators
-
Daiichi Sankyo Co., Ltd.
collaborator INDUSTRY -
Duke Clinical Research Institute
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST) · Eli Lilly and Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2012-04-30
- Completion
- 2012-04-30
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Colombia
- Costa Rica
- Croatia
- Czechia
- Denmark
- Egypt
- Finland
- France
- Germany
- Greece
- Hungary
- India
- Ireland
- Israel
- Italy
- Lithuania
- Malaysia
- Malta
- Mexico
- Netherlands
- New Zealand
- Panama
- Peru
- Philippines
- Poland
- Portugal
- Puerto Rico
- Romania
- Russia
- Serbia
- Singapore
- Slovakia
- South Africa
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Thailand
- Tunisia
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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