Assessment of platelet-dependent thrombosis by an ex vivo arterial injury model: a placebo controlled trial of Clopidogrel as antiplatelet therapy in patients with type 2 diabetes mellitus and coronary artery disease. - Platelet-dependent thrombosis: a placebo-controlled trial of antiplatelet therapy (Clopidogrel)

Phase 1

• Conditions: Type 2 Diabetes Mellitus and Coronary Artery Disease

• Registration Number: EUCTR2006-003745-16-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-02
• Study Completion: 2011-08-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1. Patients with type 2 diabetes mellitus as defined below:
Clinical Definitions
T2DM: Diagnosed according to the WHO criteria
CAD: Presence of any one of the following: Angina plus positive exercise tolerance test; enzyme and/or Q wave positive myocardial infarction; angiographic evidence (>50% stenosis of one vessel); percutaneous or surgical coronary revascularisation.
2. Aged between 18 and 75 (main study), aged 18 years and over (add-on sub-study)
3. Provided written consent for participation in the trial prior to any study-specific procedures or requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Contraindication to Clopidogrel, as per Summary of Product Characteristics
2. Smoking
3. Malignancy
4. Haematological disorders (Anaemia, malignancy, bleeding disorders)
5. Women of child-bearing potential
6. Use of corticosteroids / other antithrombotic agents
7. Chronic liver disease (Cirrhosis, malignancy and patients with abnormal liver function tests)
8. Unable to consent
9. Use of investigational study drugs within 1 year prior to study entry
10. Previous participation in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with Type 2 Diabetes Mellitus (T2DM) and Coronary Artery Disease (CAD), using an ex vivo arterial injury model.<br>;Secondary Objective: 1. To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy<br>2. To characterise features in T2DM patients responsible for increased thrombogenicity<br><br>In an add-on sub-study, to test the hypotheses:<br>1.the currently recommended doses of aspirin (75 mg) plus clopidogrel (75 mg) inhibit platelet-dependent thrombus formation more powerfully in subjects aged >75 years than in younger individuals<br>2.in the presence of diabetes, the effect of age is reduced<br><br>;Primary end point(s): Change in aorta thrombus area from baseline to final visit (i.e. over 7 days) calculated by computerised planimetry using Image-Pro Plus software (results are given as the mean of the analysed sections in u2 /mm).