Status:
COMPLETED
Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment
Lead Sponsor:
Sanofi
Conditions:
Cerebral Infarction
Eligibility:
All Genders
20-74 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1110 Patients enrolled
Trial Details
Trial ID
NCT00386191
Start Date
September 1 2006
End Date
December 1 2008
Last Update
February 24 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Tokyo, Japan