Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

Cerebral Infarction Clinical Trial

Official title:

Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386191
• Other study ID #: SFY6913
• Secondary ID: SR25990
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2006
• Last updated: February 23, 2010
• Start date: September 2006
• Est. completion date: December 2008

Study information

• Verified date: February 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1110
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• clopidogrel (SR25990C)
oral administration

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bleeding adverse events		study period	Yes
Secondary	Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.		study period	Yes