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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00335452
• Date of registration: 08/06/2006
• Primary sponsor: Sanofi-Aventis
• Public title: Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS CURRENT/OASIS7
• Scientific title: Randomized, Multinational, Double-blind Study, Comparing a High Loading Dose Regimen of Clopidogrel Versus Standard Dose in Patients With Unstable Angina or Myocardial Infarction Managed With an Early Invasive Strategy.
• Date of first enrolment: June 2006
• Target sample size: 25086
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00335452
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

• Name: Shamir MEHTA, MD
• Affiliation: Hamilton General Hospital, McMaster University, CANADA

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Coronary Disease

Angina Unstable

Intervention(s)

Drug: acetylsalicyclic acid (ASA)

Drug: Clopidogrel

Primary Outcome(s)

First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison [Time Frame: 30 days]

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison [Time Frame: 30 days]

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup [Time Frame: 30 days]

First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level [Time Frame: 30 days]

Secondary Outcome(s)

Occurrence of Major Bleeding - ASA Dose Level Comparison [Time Frame: 30 days]

Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison [Time Frame: 30 days]

Secondary ID(s)

EFC5965

EUDRACT: 2006-000313-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb