Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

Sanofi

Status and phase: Completed; Phase 4

Conditions: Cerebral Infarction

Treatments: Drug: clopidogrel (SR25990C)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386191

SFY6913

SR25990

Details and patient eligibility

About

The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.

Enrollment: 1,110 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,110 participants in 2 patient groups

1

Experimental group

Description:

50 mg

Treatment:

Drug: clopidogrel (SR25990C)

2

Experimental group

Description:

75 mg

Treatment:

Drug: clopidogrel (SR25990C)