Ex Vivo Human Thrombosis Chamber Study

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00935506
First received: July 8, 2009
Last updated: February 22, 2011
Last verified: April 2010
  Purpose

Purpose of study is to evaluate a thrombosis chamber model


Condition Intervention Phase
Cardiovascular Disease
Drug: Clopidogrel
Drug: Aspirin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluation of an Experimental EX Vivo Thrombosis Chamber Model in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Evaluate ex vivo thrombosis chamber model by assessing the effect of anti-platelet agents on thrombus formation [ Time Frame: Period 2, Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess variability of thrombosis chamber measurements [ Time Frame: Period 1 and Period 2 ] [ Designated as safety issue: No ]
  • Assess relationship between platelet aggregation and thrombus formation [ Time Frame: Period 1 and Period 2 ] [ Designated as safety issue: No ]
  • Safety and tolerability of multiple doses clopidogrel and aspirin [ Time Frame: From Day 1 through Study Discharge ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clopidogrel + Aspirin Drug: Clopidogrel
Tablets, Oral, 75 mg, Once daily, 8 days
Other Name: Plavix
Drug: Aspirin
Tablets, Oral, 325 mg, Once daily, 8 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935506

Locations
United States, New Jersey
Mds Pharma Services
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00935506     History of Changes
Other Study ID Numbers: CV197-004
Study First Received: July 8, 2009
Last Updated: February 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014