Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment
Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction
2 other identifiers
interventional
1,110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 10, 2006
CompletedFirst Posted
Study publicly available on registry
October 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFebruary 24, 2010
February 1, 2010
2.3 years
October 10, 2006
February 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of bleeding adverse events
study period
Secondary Outcomes (1)
Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.
study period
Study Arms (2)
1
EXPERIMENTAL50 mg
2
EXPERIMENTAL75 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2006
First Posted
October 11, 2006
Study Start
September 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
February 24, 2010
Record last verified: 2010-02