Clincosm LogoSign in Get a demo

Ex Vivo Human Thrombosis Chamber Study

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00935506
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
3
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose of study is to evaluate a thrombosis chamber model

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clopidogrel + Aspirin

Drug: Clopidogrel
Tablets, Oral, 75 mg, Once daily, 8 days
Other Names:
  • Plavix

    • Drug: Aspirin
    Tablets, Oral, 325 mg, Once daily, 8 days

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation [Period 2, Day 8]

    Secondary Outcome Measures

    1. Assess variability of thrombosis chamber measurements [Period 1 and Period 2]

    2. Assess relationship between platelet aggregation and thrombus formation [Period 1 and Period 2]

    3. Safety and tolerability of multiple doses clopidogrel and aspirin [From Day 1 through Study Discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mds Pharma Services Neptune New Jersey United States 07753

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00935506
    Other Study ID Numbers:
    • CV197-004
    First Posted:
    Jul 9, 2009
    Last Update Posted:
    Feb 23, 2011
    Last Verified:
    Apr 1, 2010
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Thrombosis
    Aspirin
    Clopidogrel

    Study Results

    No Results Posted as of Feb 23, 2011