Cerebral Infarction
Conditions
Keywords
Platelet Aggregation Inhibitors, Ischemic cerebrovascular disease
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.
Interventions
oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of bleeding adverse events | study period |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events. | study period |
Countries
Japan
Outcome results
None listed