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Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

Primary Purpose

Cerebral Infarction

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

clopidogrel (SR25990C)

About this trial

This is an interventional prevention trial for Cerebral Infarction focused on measuring Platelet Aggregation Inhibitors, Ischemic cerebrovascular disease

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

50 mg

75 mg

Outcomes

Primary Outcome Measures

Incidence of bleeding adverse events

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00386191

First Posted

October 10, 2006

Last Updated

February 23, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00386191

Brief Title

Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Infarction

Keywords

Platelet Aggregation Inhibitors, Ischemic cerebrovascular disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

50 mg

Arm Title

Arm Type

Experimental

Arm Description

75 mg

Intervention Type

Drug

Intervention Name(s)

clopidogrel (SR25990C)

Intervention Description

oral administration

Primary Outcome Measure Information:

Title

Incidence of bleeding adverse events

Time Frame

study period

Secondary Outcome Measure Information:

Title

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

Time Frame

study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Tokyo

Country

Japan

12. IPD Sharing Statement

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Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

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