Additional identifiers
EudraCT number
2009-011907-22
ClinicalTrials.gov number
Protocol/serial number
7863
Study information
Scientific title
Antiplatelet Treatment in Diabetes
Acronym
DRN 416
Study hypothesis
Cardiovascular disease is the major cause of death in patients with diabetes. Aspirin is recommended as primary and secondary prevention for cardiovascular disease and it has proven clinical efficacy. However, recent studies suggest it may have limited effectiveness in people with diabetes, which may be dose-related and may be related to blood sugar levels, which are usually raised in diabetes. Clopidogrel may be used as a alternative to aspirin in secondary prevention and Prasugrel is licensed for use in conjunction with aspirin, but not alone. All three are antiplatelet agents but they have differing modes of action. This study will compare the effects of these agents on clot structure and platelet function in people with type 2 diabetes. It will also increase knowledge of the influence varying blood sugar levels have on the effects of these agents.
Ethics approval
MREC approved, ref: 09/H1307/110
Study design
Single-centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease
Intervention
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
Intervention type
Drug
Phase
Phase II/III
Drug names
Clopidogrel, prasugrel, aspirin
Primary outcome measure
Comparison of the biochemical efficacy of aspirin, clopidogrel and prasugrel in subjects with type 2 diabetes
Secondary outcome measures
To study the mechanisms of antiplatelet treatment failure in individuals with type 2 diabetes
Overall trial start date
01/05/2010
Overall trial end date
30/04/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 56; UK sample size: 56
Participant 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.
Recruitment start date
01/05/2010
Recruitment end date
30/04/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9JT
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Eli Lilly and Company Limited (UK) (ref: H7T-BP-0003)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list