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)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003745-16-GB

Enrollment

225

Registered

2008-09-02

Start date

2008-10-28

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Type 2 Diabetes Mellitus and Coronary Artery Disease

Interventions

Trade Name: PLAVIX Pharmaceutical Form: Film-coated tablet INN or Proposed INN: clopidogrel hydrogen sulphate 97.875mg (molar equivalent of 75mg of clopidogrel base) Concentration unit: mg milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ;Secondary Objective: 1. To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy 2. To characterise features in T2DM patients responsible for increased thrombogenicity In an add-on sub-study, to test the hypotheses: 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 2.in the presence of diabetes, the effect of age is reduced ;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).	—

Measure

Time frame

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. ;Secondary Objective: 1. To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy 2. To characterise features in T2DM patients responsible for increased thrombogenicity In an add-on sub-study, to test the hypotheses: 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 2.in the presence of diabetes, the effect of age is reduced ;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).

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026