Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment
- Registration Number
- NCT00386191
- Lead Sponsor
- Sanofi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1110
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
Read More
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.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 clopidogrel (SR25990C) 50 mg 2 clopidogrel (SR25990C) 75 mg
- Primary Outcome Measures
Name Time Method Incidence of bleeding adverse events study period
- Secondary Outcome Measures
Name Time Method Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events. study period
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇯🇵Tokyo, Japan