Antiplatelet Treatment in Diabetes

ISRCTN	ISRCTN79817966
DOI	https://doi.org/10.1186/ISRCTN79817966
EudraCT/CTIS number	2009-011907-22
Secondary identifying numbers	7863

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 23/06/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ramzi Ajjan
Scientific

University of Leeds
Leeds Institute of Genetic Health and Therapeutics
Leeds
LS2 9JT
United Kingdom

Study information

Study design	Single-centre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Antiplatelet Treatment in Diabetes
Study acronym	DRN 416
Study objectives	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(s)	MREC approved, ref: 09/H1307/110
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	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 study start date	01/05/2010
Completion date	30/04/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 56; UK sample size: 56
Total final enrolment	56
Key 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
Key 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.
Date of first enrolment	01/05/2010
Date of final enrolment	30/04/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Leeds

Leeds
LS2 9JT
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

Website	http://www.leeds.ac.uk/
"ROR"	https://ror.org/024mrxd33

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			23/06/2020	No	No
HRA research summary			28/06/2023	No	No

Editorial Notes

23/06/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
10/09/2019: No publications found, verifying study status with principal investigator.
09/11/2017: No publications found in PubMed, verifying study status with principal investigator.