Ex Vivo Human Thrombosis Chamber Study | NCT00935506

Studies
Ex Vivo Human Thrombosis Chamber Study

NCT00935506

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Feb 23, 2011Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Cardiovascular Disease

Interventions

Clopidogrel
Aspirin

Countries

United States

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

Status Module

Record Verification Date

Apr 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

Jul 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jul 8, 2009

First Submission Date that Met QC Criteria

Jul 8, 2009

First Posted Date

Jul 9, 2009Estimated

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 22, 2011

Last Update Posted Date

Feb 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clopidogrel + Aspirin	Experimental		Drug: Clopidogrel Drug: Aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clopidogrel	Drug	Tablets, Oral, 75 mg, Once daily, 8 days	Clopidogrel + Aspirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation		Period 2, Day 8

Secondary Outcomes

Measure	Description	Time Frame
Assess variability of thrombosis chamber measurements		Period 1 and Period 2
Assess relationship between platelet aggregation and thrombus formation		Period 1 and Period 2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Subjects
BMI 18-30 kg/m²
Male ages 18-45

Exclusion Criteria:

Significant acute or chronic illness
History of abnormal bleeding or coagulation disorder, intracranial hemorrhage, or a family history of abnormal bleeding or coagulation disorder in a first degree relative under 50 years of age
Easy bruising
Smoking within 3 months prior to Day 1

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mds Pharma Services		Neptune City	New Jersey	07753	United States

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077144	Clopidogrel
D001241	Aspirin

Ancestor Terms

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds

Browse Leaves

Not provided

Browse Branches

Not provided