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CompletedNCT00935506Updated Feb 23, 2011

Ex Vivo Human Thrombosis Chamber Study

A Phase 1 interventional study of Clopidogrel and Aspirin in Cardiovascular Disease, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-23.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

Purpose of study is to evaluate a thrombosis chamber model

02

Conditions studied

  • Cardiovascular Disease
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Subjects
  • BMI 18-30 kg/m²
  • Male ages 18-45

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Clopidogrel + Aspirin

    Drug: Clopidogrel · Drug: Aspirin

Interventions

  • DrugClopidogrel

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

    Also known as: Plavix

  • DrugAspirin

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

06

What researchers measure

Primary outcomes

  1. Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation

    Time frame: Period 2, Day 8

Secondary outcomes

  1. Assess variability of thrombosis chamber measurements

    Time frame: Period 1 and Period 2

  2. Assess relationship between platelet aggregation and thrombus formation

    Time frame: Period 1 and Period 2

  3. Safety and tolerability of multiple doses clopidogrel and aspirin

    Time frame: From Day 1 through Study Discharge

07

Study locations

1 site
  • Mds Pharma Services
    Neptune, New Jersey 07753, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00935506
Lead sponsor
Bristol-Myers Squibb
First posted
Jul 9, 2009
Start date
Jul 2009
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Feb 23, 2011

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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