The ASP Study (Protocol v1.0 dated 4th July 2011)

• Research type

  Research Study

• Full title

  The impact of single versus double dose acetylsalicylic acid on platelet function in patients with type 2 diabetes (the "ASP Study").

• IRAS ID

  62911

• Contact name

  Rury Holman

• Sponsor organisation

  University of Oxford

• Eudract number

  2011-003123-35

• ISRCTN Number

  TBA

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  A pilot study of single versus double dose aspirin on platelet function in type 2 diabetic patients: "The ASP Study"Type 2 diabetics have increased risk of heart disease, possibly partially explained by research findings that platelets in diabetic patients are over-active, allowing blood to clot more easily and block blood vessels of the heart and other tissues. Aspirin (ASA), a medicine that reduces platelet activity, is recommended for diabetic patients with known heart disease to reduce the likelihood of a heart attack or stroke. Whether aspirin reduces the risk of a first heart attack in diabetic patients is unclear.This study aims to examine whether single (100mg) or double (200 mg) doses of ASA can inhibit effectively platelet function in diabetic patients without heart disease and to determine whether the double dose is more effective when given as 100mg twice daily. The study is designed as a ??cross-over? trial so that each patient will receive each of the following treatments random order: ?½ASA 100mg daily for 2 weeks?½ASA 100mg twice daily for 2 weeks?½ASA 200mg daily for 2 weeks Platelet function is assessed with blood tests at baseline and at the end of each treatment period. There is a 2-week break between treatments (a ??wash-out period) so that each ASA dose is cleared before beginning the next regimen.The study will involve 24 individuals <55 years old, with no prior history of heart disease or stroke and with type 2 diabetes not requiring insulin. These individuals should have had stable health for at least the last 3 months (including general health and medication regimen). 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 our research team.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1200

• Date of REC Opinion

  24 Aug 2011

• REC opinion

  Favourable Opinion