Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS

Completed · Phase 3

Conditions studied: Acute Coronary Disease, Angina Unstable

In brief

The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).

Key facts

Study ID

NCT00335452

Run by

Sanofi

People needed

25086

Starts

2006-06-01

Expected to finish

2009-09-01

Last updated by the study team

2010-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated

You may not qualify if…

• Use of anticoagulants within 10 days with an international normalized ratio (INR) > 1.5 or planned use during the hospitalisation period
• Administration of clopidogrel > 75 mg prior to randomization
• Contraindication to clopidogrel or aspirin
• Active bleeding or significant risk of bleeding

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• sanofi-aventis Australia & New Zealand administrative office — Macquarie Park, Australia
• Sanofi-Aventis Administrative Office — Vienna, Austria
• Sanofi-Aventis Administrative Office — Diegem, Belgium
• Sanofi-Aventis Administrative Office — São Paulo, Brazil
• Sanofi-Aventis Administrative Office — Sofia, Bulgaria
• Sanofi-Aventis Administrative Office — Laval, Canada
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Beijing, China
• Sanofi-Aventis Administrative Office — Zagreb, Croatia
• Sanofi-Aventis Administrative Office — Prague, Czechia
• Sanofi-Aventis Administrative Office — Tallinn, Estonia
• Sanofi-Aventis Administrative Office — Helsinki, Finland
• Sanofi-Aventis Administrative Office — Paris, France
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Athens, Greece
• Sanofi-Aventis Administrative Office — Mumbai, India
• Sanofi-Aventis Administrative Office — Dublin, Ireland
• Sanofi-Aventis Administrative Office — Netanya, Israel
• Sanofi-Aventis Administrative Office — Milan, Italy
• Sanofi-Aventis Administrative Office — Riga, Latvia
• Sanofi-Aventis Administrative Office — Vilnius, Lithuania
• Sanofi-Aventis Administrative Office — Kuala Lumpur, Malaysia
• Sanofi-Aventis Administrative Office — México, Mexico

Full record on ClinicalTrials.gov

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