Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Clopidogrel; Platelet Aggregation Inhibitors; Ticlopidine

Criteria

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.