NCT00935506

Brief Summary

Purpose of study is to evaluate a thrombosis chamber model

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 23, 2011

Status Verified

April 1, 2010

Enrollment Period

3 months

First QC Date

July 8, 2009

Last Update Submit

February 22, 2011

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

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

    Period 2, Day 8

Secondary Outcomes (3)

  • 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

Study Arms (1)

Clopidogrel + Aspirin

EXPERIMENTAL
Drug: ClopidogrelDrug: Aspirin

Interventions

ClopidogrelDRUG

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

Also known as: Plavix
Clopidogrel + Aspirin
AspirinDRUG

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

Clopidogrel + Aspirin

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mds Pharma Services

Neptune City, New Jersey, 07753, United States

Location

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

ClopidogrelAspirin

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 9, 2009

Study Start

July 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 23, 2011

Record last verified: 2010-04

Locations

US(1)