Ex Vivo Human Thrombosis Chamber Study

Cardiovascular Disease Clinical Trial

Official title:

Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935506
• Other study ID #: CV197-004
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2009
• Last updated: February 22, 2011
• Start date: July 2009
• Est. completion date: October 2009

Study information

• Verified date: April 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Purpose of study is to evaluate a thrombosis chamber model

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Clopidogrel
Tablets, Oral, 75 mg, Once daily, 8 days
• Aspirin
Tablets, Oral, 325 mg, Once daily, 8 days

Locations

Country	Name	City	State
United States	Mds Pharma Services	Neptune	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation		Period 2, Day 8	No
Secondary	Assess variability of thrombosis chamber measurements		Period 1 and Period 2	No
Secondary	Assess relationship between platelet aggregation and thrombus formation		Period 1 and Period 2	No
Secondary	Safety and tolerability of multiple doses clopidogrel and aspirin		From Day 1 through Study Discharge	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form