Antiplatelet Treatment in Diabetes

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN79817966
• Date of registration: 12/05/2010
• Primary sponsor: University of Leeds (UK)
• Public title: Antiplatelet Treatment in Diabetes DRN 416
• Date of first enrolment: May 1 2010
• Target sample size: Planned sample size: 56; UK sample size: 56
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN79817966
• Study type: Interventional
• Study design: Single centre randomised interventional treatment trial

Countries of recruitment

United Kingdom

Contacts

• Name: Ramzi Ajjan

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 less than 75 years, either sex
2. Type 2 diabetes mellitus
3. Currently taking aspirin 75 mg per day
4. Weight 60 kg or over
5. Must be able to give informed consent and comply with the protocol
7. Using reliable contraception, i.e., oral contraceptive pill, intrauterine
device, diaphragm + condom
Exclusion criteria: 1. Prior treatment with clopidogrel or prasugrel
2. Previous or current treatment with warfarin or non-steroidal inflammatory drugs (NSAID)
3. A history of acute coronary syndrome within 3 months of recruitment
4. Any history of coagulation or bleeding disorder, neoplastic disease, deep vein thrombosis, pulmonary embolism
5. Any previous or current upper gastrointestinal pathology
6. Any history of cerebral vascular accident or transient ischaemic attack
hypersensitiviy to the active substance (i.e., clopidogrel or prasugrel) or any of the excipients
7. Active pathological bleeding
8. Any individual found to have abnormal liver function (measured by alanine aminotransferase [ALT] greater than 3 times upper limit of normal) or abnormal thyroid function will be excluded at this time and offered further investigation
9. Weight less than 60 kg
10. Inadequate contraception (as described in inclusion criteria)
11. Pregnant and lactating women. In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease

Intervention(s)

Subjects with type 2 diabetes currently taking aspirin 75 mg. Following a 2-week run in period, they will be randomised to receive either clopidogrel 75 mg or prasugrel 10 mg daily for 4 weeks. Following this they will be switched to receive whichever treatment they did not receive during the first phase. At the end of a further 4 weeks study treatment they will recommence aspirin therapy as before.

Follow-up length: 4 months
Study entry: single randomisation only

Primary Outcome(s)

Comparison of the biochemical efficacy of aspirin, clopidogrel and prasugrel in subjects with type 2 diabetes

Secondary Outcome(s)

To study the mechanisms of antiplatelet treatment failure in individuals with type 2 diabetes

Secondary ID(s)

7863

Source(s) of Monetary Support

Eli Lilly and Company Limited (UK) (ref: H7T-BP-0003)

Secondary Sponsor(s)

N/A