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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00335452
Recruitment Status : Completed
First Posted : June 9, 2006
Results First Posted : October 7, 2010
Last Update Posted : November 18, 2010
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE June 8, 2006
First Posted Date  ICMJE June 9, 2006
Results First Submitted Date  ICMJE September 15, 2010
Results First Posted Date  ICMJE October 7, 2010
Last Update Posted Date November 18, 2010
Study Start Date  ICMJE June 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
  • First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison [ Time Frame: 30 days ]
    The primary endpoint is the first occurrence of any of the following events:
    • Cardiovascular death (any death with a clear cardiovascular or unknown cause),
    • Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal)
    • Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal)
    reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
  • First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison [ Time Frame: 30 days ]
  • First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level [ Time Frame: 30 days ]
  • First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2006)
At Day 30 , first occurrence of cardiovascular death, myocardial infarction and stroke; second co-primary outcome: first occurrence of cardiovascular death, stroke, myocardial infarction and recurrent ischemia
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2010)
  • Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison [ Time Frame: 30 days ]
    Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.
  • Occurrence of Major Bleeding - ASA Dose Level Comparison [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2006)
At Day 30, rate of major bleeding
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
Official Title  ICMJE 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.
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 infarction (MI), stroke) after a percutaneous coronary intervention (PCI).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Coronary Disease
  • Angina Unstable
Intervention  ICMJE
  • Drug: Clopidogrel
    oral administration
    Other Names:
    • SR25990
    • Plavix
  • Drug: acetylsalicyclic acid (ASA)
    oral administration
Study Arms  ICMJE
  • Experimental: Clopidogrel high dose treatment regimen + ASA high dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: acetylsalicyclic acid (ASA)
  • Experimental: Clopidogrel high dose treatment regimen + ASA low dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: acetylsalicyclic acid (ASA)
  • Active Comparator: Clopidogrel standard treatment regimen + ASA high dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: acetylsalicyclic acid (ASA)
  • Active Comparator: Clopidogrel standard treatment regimen + ASA low dose
    Interventions:
    • Drug: Clopidogrel
    • Drug: acetylsalicyclic acid (ASA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2010)
25086
Original Enrollment  ICMJE
 (submitted: June 8, 2006)
14000
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Croatia,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Greece,   India,   Ireland,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries Denmark,   Hungary,   Norway,   Philippines
 
Administrative Information
NCT Number  ICMJE NCT00335452
Other Study ID Numbers  ICMJE EFC5965
EUDRACT: 2006-000313-38
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Shamir MEHTA, MD Hamilton General Hospital, McMaster University, CANADA
PRS Account Sanofi
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP