Antiplatelet treatment in patients with diabetes mellitus: is there a difference between aspirin, clopidogrel and prasugrel - Antiplatelet Treatment in Diabetes
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- EUCTR2009-011907-22-GB
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
Age 18 - <75
Type 2 diabetes mellitus
currently taking aspirin 75mg per day
Weight 60kg or over
Must be able to give informed consent and comply with the protocol
Using reliable contraception ie. oral contraceptive pill, intra-uterine device, diaphragm + condom
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
prior treatment with clopidogrel or prasugrel
previous or current treatment with warfarin or non-steroidal inflammatory drugs
a history of acute coronary syndrome within 3 months of recruitment
any history of coagulation or bleeding disorder, neoplastic disease, deep vein thrombosis, pulmonary embolism. Any previous or current upper gastrointestinal pathology
any history of cerabral vascular accident or transient ischaemic attack
hypersensitiviy to the active substance (ie clopidogrel or prasugrel) or any of the excipients
active pathological bleeding
any individual found to have abnormal liver function (measured by ALT>3times upper limit of normal) or abnormal thyroid function will be excluded at this time and offered further investigation
Weight less than 60kg
inadequate contraception (as described in inclusion criteria)
pregnant and lactating women will be excluded. In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn
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 biochemical efficacy of Aspirin, Clopidegrel and Prasugrel in subjects with type 2 diabetes using a dual approach that investigates both platelet function and clot structure/fibrinolysis;Secondary Objective: To study the mechanisms of antiplatelet treatment failure in individuals with type 2 diabetes;Primary end point(s): Platelet activation and different parameters of clot structure/function
- Secondary Outcome Measures
Name Time Method