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)

ewcastle upon Tyne Hospitals NHS Trust0 个研究点目标入组 225 人开始时间: 2008年9月2日最近更新: 2020年10月13日

适应症

试验速览

暂无简介。

•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

•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

发起方

ewcastle upon Tyne Hospitals NHS Trust