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Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

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. Identifier: NCT00386191
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : February 24, 2010
Information provided by:

Brief Summary:
The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: clopidogrel (SR25990C) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction
Study Start Date : September 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
50 mg
Drug: clopidogrel (SR25990C)
oral administration

Experimental: 2
75 mg
Drug: clopidogrel (SR25990C)
oral administration

Primary Outcome Measures :
  1. Incidence of bleeding adverse events [ Time Frame: study period ]

Secondary Outcome Measures :
  1. Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events. [ Time Frame: study period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented
  • Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image
  • Body weight : > 50 kg

Exclusion Criteria:

  • Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement)
  • Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction
  • Patients with serious impairment that would hinder detection of new ischemic event
  • Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease
  • Patients with history of intracranial hemorrhage
  • Patients with diabetic retinopathy
  • Hypertensive patients with a persistent increase of blood pressure.

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 identifier (NCT number): NCT00386191

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Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi

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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00386191     History of Changes
Other Study ID Numbers: SFY6913
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: February 24, 2010
Last Verified: February 2010

Keywords provided by Sanofi:
Platelet Aggregation Inhibitors
Ischemic cerebrovascular disease

Additional relevant MeSH terms:
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Cerebral Infarction
Pathologic Processes
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs