Ex Vivo Human Thrombosis Chamber Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Disease

Treatments: Drug: Clopidogrel; Drug: Aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00935506

CV197-004

Details and patient eligibility

About

Purpose of study is to evaluate a thrombosis chamber model

Enrollment: 15 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Clopidogrel + Aspirin

Experimental group

Treatment:

Drug: Aspirin

Drug: Clopidogrel