Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
22/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ramzi Ajjan

ORCID ID

Contact details

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

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 measures

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

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

http://www.leeds.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes