Safety and Efficacy of Clopidogrel for Cerebral Infarctio... | NCT00386191

Studies
Safety and Efficacy of Clopidogrel for Cerebral Infarction Treatment

NCT00386191

Sponsor

Sanofi

Status

Completed

Last Update Posted

Feb 24, 2010Estimated

Enrollment

1,110Actual

Phase

Phase 4

Conditions

Cerebral Infarction

Interventions

clopidogrel (SR25990C)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SR25990

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 10, 2006

First Submission Date that Met QC Criteria

Oct 10, 2006

First Posted Date

Oct 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2010

Last Update Posted Date

Feb 24, 2010Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	50 mg	Drug: clopidogrel (SR25990C)
2	Experimental	75 mg	Drug: clopidogrel (SR25990C)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clopidogrel (SR25990C)	Drug	oral administration	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of bleeding adverse events		study period

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events.		study period

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D002544	Cerebral Infarction

Ancestor Terms

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077144	Clopidogrel

Ancestor Terms

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided