Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00386191

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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
1: Experimental 50 mg	Drug: clopidogrel (SR25990C) oral administration
2: Experimental 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

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

Locations

Japan
Sanofi-aventis Administrative Office
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	SFY6913, SR25990
Study First Received:	October 10, 2006
Last Updated:	January 19, 2010
ClinicalTrials.gov Identifier:	NCT00386191 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

Platelet Aggregation Inhibitors
Ischemic cerebrovascular disease

Additional relevant MeSH terms:

Cerebral Infarction
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions

Necrosis
Pathologic Processes
Therapeutic Uses
Clopidogrel
Brain Ischemia
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Brain Infarction
Infarction

ClinicalTrials.gov processed this record on February 08, 2010