Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Efient
Product Name: prasugrel hydrochloride
Product Code: LY640315
Pharmaceutical Form: Coated tablet
INN or Proposed INN:
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18 - =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed