Antiplatelet Treatment in Diabetes

Phase 2

Completed

• Conditions: Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN79817966
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-12
• Study Completion: 2012-04-30
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

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 In the unlikely event of pregnancy during the study, the individual will be immediately withdrawn.

Study & Design

• Study Type: Interventional
• Study Design: Not specified