Ex Vivo Human Thrombosis Chamber Study

NCT ID: NCT00935506

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-10-31

Brief Summary

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Purpose of study is to evaluate a thrombosis chamber model

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Clopidogrel + Aspirin

Group Type EXPERIMENTAL

Clopidogrel

Intervention Type DRUG

Tablets, Oral, 75 mg, Once daily, 8 days

Aspirin

Intervention Type DRUG

Tablets, Oral, 325 mg, Once daily, 8 days

Interventions

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Clopidogrel

Tablets, Oral, 75 mg, Once daily, 8 days

Intervention Type DRUG

Aspirin

Tablets, Oral, 325 mg, Once daily, 8 days

Intervention Type DRUG

Other Intervention Names

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Plavix

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Mds Pharma Services

Neptune City, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV197-004

Identifier Type: -

Identifier Source: org_study_id

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