Extrait

Background and study aims? People with type 2 diabetes have an increased risk of heart disease, possibly partially explained by research findings that platelets (the small fragments of cells that help blood to clot) in diabetic patients are over-active, allowing their blood to clot more easily and possibly block blood vessels to the heart and other organs. Aspirin (ASA), a medicine that reduces platelet activity, is recommended for diabetic patients who already have heart disease to reduce the likelihood of a further heart attack or stroke. Whether aspirin reduces the risk of a first heart attack or stroke in diabetic patients is unclear. This study will examine whether single (100 mg) or double (200 mg) doses of ASA can reduce platelet function successfully in diabetic patients without heart disease and will determine whether the double dose works better when given as a single dose or 100mg twice daily. Who can participate? Patients without a history of heart disease or stroke between the age of 18-75 years who have type 2 diabetes controlled by diet or stable doses of anti-hyperglycaemic medication. What does the study involve? The study is designed in a way that that each participant will receive each treatment for 2 week periods in random order as follows: • ASA 100 mg once daily • ASA 200 mg once daily • ASA 100 mg twice daily Platelet function will be assessed by blood tests at the beginning and at the end of each treatment period. There will be a 2-week break between treatments to ensure that the ASA effects have been ‘washed out’ before beginning the next treatment period. The study will last approximately 12 weeks for each patient and involve a maximum of 5 study visits to the Churchill Hospital and 3 telephone contacts from the research team. Where is the study run from? The Clinical Research Unit (CRU) at the Oxford Centre for Diabetes, Endocrinology & Metabolism (OCDEM), Churchill Hospital Oxford, will perform this study which is sponsored by the University of Oxford. What are the possible benefits and risks of participating? There are no direct benefits of taking part in this initial study but the results could help researchers to design a large-scale study that may lead to future important medical findings such as identifying the best way to treat patients with type 2 diabetes in order to prevent heart attacks and strokes. The risks of participating in this study are limited. Aspirin has been associated with minor bleeding, such as a nose-bleed or bruising. Severe bleeding with aspirin occurs very rarely. The health of each study patient will be monitored during the study and the study medication will be stopped should there be any cause for concern. When is the study starting and how long is it expected to run for? November 2011 to January 2013 Who is funding the study? It is funded by the British Heart Foundation charity. Who is the main contact? The Diabetes Trial Unit [email protected]

Critère d'inclusion

• Diabetes type 2

Liens

• ictrp
• isrctn