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

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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

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).

Condition or disease Intervention/treatment Phase
Acute Coronary Disease Angina Unstable Drug: Clopidogrel Drug: acetylsalicyclic acid (ASA) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25086 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : June 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Clopidogrel high dose treatment regimen + ASA high dose Drug: Clopidogrel
oral administration
Other Names:
  • SR25990
  • Plavix

Drug: acetylsalicyclic acid (ASA)
oral administration

Experimental: Clopidogrel high dose treatment regimen + ASA low dose Drug: Clopidogrel
oral administration
Other Names:
  • SR25990
  • Plavix

Drug: acetylsalicyclic acid (ASA)
oral administration

Active Comparator: Clopidogrel standard treatment regimen + ASA high dose Drug: Clopidogrel
oral administration
Other Names:
  • SR25990
  • Plavix

Drug: acetylsalicyclic acid (ASA)
oral administration

Active Comparator: Clopidogrel standard treatment regimen + ASA low dose Drug: Clopidogrel
oral administration
Other Names:
  • SR25990
  • Plavix

Drug: acetylsalicyclic acid (ASA)
oral administration




Primary Outcome Measures :
  1. 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).


  2. First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison [ Time Frame: 30 days ]
  3. First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level [ Time Frame: 30 days ]
  4. First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 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.

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335452


  Show 38 Study Locations
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Principal Investigator: Shamir MEHTA, MD Hamilton General Hospital, McMaster University, CANADA

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00335452     History of Changes
Other Study ID Numbers: EFC5965
EUDRACT: 2006-000313-38
First Posted: June 9, 2006    Key Record Dates
Results First Posted: October 7, 2010
Last Update Posted: November 18, 2010
Last Verified: November 2010

Keywords provided by Sanofi:
platelet aggregation inhibitors
acute coronary disease
percutaneous coronary

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors