Back to resultsEx Vivo Human Thrombosis Chamber Study
Primary Purpose
Cardiovascular Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clopidogrel
Aspirin
Sponsored by
About this trial
This is an interventional basic science trial for Cardiovascular Disease
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
Sites / Locations
- Mds Pharma Services
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clopidogrel + Aspirin
Arm Description
Outcomes
Primary Outcome Measures
Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation
Secondary Outcome Measures
Assess variability of thrombosis chamber measurements
Assess relationship between platelet aggregation and thrombus formation
Safety and tolerability of multiple doses clopidogrel and aspirin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00935506
Brief Title
Ex Vivo Human Thrombosis Chamber Study
Official Title
Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Purpose of study is to evaluate a thrombosis chamber model
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clopidogrel + Aspirin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
Tablets, Oral, 75 mg, Once daily, 8 days
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Tablets, Oral, 325 mg, Once daily, 8 days
Primary Outcome Measure Information:
Title
Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation
Time Frame
Period 2, Day 8
Secondary Outcome Measure Information:
Title
Assess variability of thrombosis chamber measurements
Time Frame
Period 1 and Period 2
Title
Assess relationship between platelet aggregation and thrombus formation
Time Frame
Period 1 and Period 2
Title
Safety and tolerability of multiple doses clopidogrel and aspirin
Time Frame
From Day 1 through Study Discharge
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Mds Pharma Services
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
12. IPD Sharing Statement
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Ex Vivo Human Thrombosis Chamber Study
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