Antiplatelet Treatment in Diabetes

• Research type

  Research Study

• Full title

  Antiplatelet treatment in patients with diabetes mellitus: is there a difference between aspirin, clopidogrel and prasugrel

• IRAS ID

  22934

• Contact name

  Ramzi Ajjan

• Sponsor organisation

  University of Leeds

• Eudract number

  2009-011907-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Diabetes is associated with increased risk of vascular disease compared to the non-diabetic population, including heart attack and stroke. Cardiovascular disease is the major cause of death in people with diabetes. This results in frequent hospital admissions with cost implications to the National Health Service. Aspirin is currently used as primary or secondary prevention for heart disease. Clopidogrel is used as an alternative secondary prevention. Aspirin has proven efficacy, but recent studies suggest it may have less or no effect in people with diabetes, which may be dose-related or may be related to blood sugar levels which are usually raised in people with diabetes. Prasugrel is licensed for use in conjunction with aspirin but not alone. All 3 are antiplatelet treatments but work differently. Platelets are cells involved in the formation of blood clots. Aspirin inhibits platelet function and also affects the molecules that form the blood clot. Clopidogrel and Prasugrel also inhibit platelet function through a different pathway but their effect on blood clots is unknown. To investigate this we will use a number of different laboratory tests to analyse clot structure, platelet function and fibrinolysis (the breaking down of blood clots). This study will recruit 56 people with type 2 diabetes attending the diabetes centre at the Leeds General Infirmary, aged 18-75, who are currently taking 75mg of aspirin per day. This is a double-blind, randomised, crossover study. Each participant will be seen 2 weeks after recruitment when they will discontinue aspirin treatment and be randomised to receive either Clopidogrel or Prasugrel instead. After 4 weeks they will be crossed over to receive the drug they did not receive during the first phase of the study for a further 4 weeks. This will complete the study and they will recommence Aspirin therapy as before the study.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/110

• Date of REC Opinion

  15 Jan 2010

• REC opinion

  Further Information Favourable Opinion