Ex Vivo Human Thrombosis Chamber Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00935506

Enrollment

Registered

2009-07-09

Start date

2009-07-31

Completion date

2009-10-31

Last updated

2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Brief summary

Purpose of study is to evaluate a thrombosis chamber model

Interventions

DRUGClopidogrel

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

DRUGAspirin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026