Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

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

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel (SR25990C)

Drug

oral administration

Primary outcomes

Incidence of bleeding adverse events

Time frame: study period

Secondary outcomes

Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.

Time frame: study period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Oct 11, 2006
Registry last updated: Feb 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed