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

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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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