Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Infarction
Intervention: Clopidogrel (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Yuko HARADA, Study Director, Affiliation: Sanofi-Aventis
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.
Clinical Details
Official title: Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction
Study design: Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of bleeding adverse events
Secondary outcome: Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.
Eligibility
Minimum age: 20 Years.
Maximum age: 74 Years.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis, Tokyo, Japan
Additional Information
Starting date: September 2006
Last updated: October 26, 2007
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