Ex Vivo Human Thrombosis Chamber Study

Phase 1

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: Clopidogrel; Drug: Aspirin

• Registration Number: NCT00935506
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Purpose of study is to evaluate a thrombosis chamber model

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-04
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clopidogrel + Aspirin	Clopidogrel	-
Clopidogrel + Aspirin	Aspirin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assess relationship between platelet aggregation and thrombus formation	Period 1 and Period 2
Assess variability of thrombosis chamber measurements	Period 1 and Period 2
Safety and tolerability of multiple doses clopidogrel and aspirin	From Day 1 through Study Discharge

Trial Locations

Locations (1)

Mds Pharma Services; 🇺🇸 Neptune, New Jersey, United States