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OpenTrials
Completed

NCT Number: NCT00935506

Ex Vivo Human Thrombosis Chamber Study

Purpose of study is to evaluate a thrombosis chamber model

Completed

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Mds Pharma Services

Neptune City, New Jersey, 07753, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

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

Other names: Plavix

Aspirin

Drug

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

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 9, 2009
Registry last updated
Feb 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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