Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS (CURRENT/OASIS7)

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Angina Unstable
Acute Coronary Disease

Treatments

Drug: Clopidogrel
Drug: acetylsalicyclic acid (ASA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00335452
EFC5965
EUDRACT: 2006-000313-38

Details and patient eligibility

About

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).

Enrollment

25,086 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

25,086 participants in 4 patient groups

Clopidogrel high dose treatment regimen + ASA high dose
Experimental group
Treatment:
Drug: acetylsalicyclic acid (ASA)
Drug: Clopidogrel
Clopidogrel high dose treatment regimen + ASA low dose
Experimental group
Treatment:
Drug: acetylsalicyclic acid (ASA)
Drug: Clopidogrel
Clopidogrel standard treatment regimen + ASA high dose
Active Comparator group
Treatment:
Drug: acetylsalicyclic acid (ASA)
Drug: Clopidogrel
Clopidogrel standard treatment regimen + ASA low dose
Active Comparator group
Treatment:
Drug: acetylsalicyclic acid (ASA)
Drug: Clopidogrel

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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