Ex Vivo Human Thrombosis Chamber Study

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

Purpose of study is to evaluate a thrombosis chamber model

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Drug: Clopidogrel; Drug: Aspirin

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • MDS Pharma Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clopidogrel + Aspirin	Drug: Clopidogrel; Tablets, Oral, 75 mg, Once daily, 8 days; Other Names: Plavix; Drug: Aspirin; Tablets, Oral, 325 mg, Once daily, 8 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 8, 2009
• First Posted (Estimate): July 9, 2009

Study Record Updates

• Last Update Posted (Estimate): February 23, 2011
• Last Update Submitted That Met QC Criteria: February 22, 2011
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Embolism and Thrombosis; Cardiovascular Diseases; Thrombosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: CV197-004