Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00386191
First received: October 10, 2006
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Cerebral Infarction
Drug: clopidogrel (SR25990C)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Safety and Efficacy of Clopidogrel sulfate50mg and Clopidogrel Sulfate 75mg for the Treatment of Cerebral Infarction

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Incidence of bleeding adverse events [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events. [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Enrollment: 1110
Study Start Date: September 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
50 mg
Drug: clopidogrel (SR25990C)
oral administration
Experimental: 2
75 mg
Drug: clopidogrel (SR25990C)
oral administration

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386191

Locations
Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00386191     History of Changes
Other Study ID Numbers: SFY6913, SR25990
Study First Received: October 10, 2006
Last Updated: February 23, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
Platelet Aggregation Inhibitors
Ischemic cerebrovascular disease

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014