Status:

COMPLETED

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

Lead Sponsor:

Sanofi

Collaborating Sponsors:

Bristol-Myers Squibb

Conditions:

Acute Coronary Disease

Angina Unstable

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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 infarcti...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2009

Estimated Enrollment :

25086 Patients enrolled

Trial Details

Trial ID

NCT00335452

Start Date

June 1 2006

End Date

September 1 2009

Last Update

November 18 2010

Active Locations (38)

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Page 1 of 10 (38 locations)

1

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States, 08807

2

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

3

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, Australia

4

Sanofi-Aventis Administrative Office

Vienna, Austria

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