Coronary Artery Disease, Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes mellitus, Coronary artery disease, Platelet dependent thrombogenicity, Aspirin, Clopidogrel, Badimon Chamber
Brief summary
Patients with diabetes are more likely to develop furring of their coronary arteries and present with angina and heart attacks. Furthermore, after such an event, they have poorer outcomes (higher rates of death) and survivors are more likely to have recurring symptoms. Using a novel clotting chamber the investigators have shown that patients with diabetes are more likely to develop blood clots. This study will look at the role of different blood thinning medications in patients with diabetes. If successful, the investigators will provide evidence to conduct large clinical studies to look at the role of additional blood thinning medication in reducing heart attacks and strokes in patients with diabetes.
Detailed description
The objective of this study is to compare the effect of Clopidogrel on platelet dependent thrombosis in patients with T2DM and CAD with placebo. The Badimon chamber, an ex vivo arterial injury model is used for this purpose. This model simulates the in vivo situation of high shear arterial wall damage and helps to quantify thrombus which is the sum endpoint of all haemostatic abnormalities seen in vitro.
Interventions
DRUGclopidogrel
75 milligrams, oral, clopidogrel, one tablet daily, for seven days after the baseline chamber study.
DRUGplacebo
Placebo: Hydroxy methyl cellulose, similar in weight to the active medication 75 mgs, oral tablets, once a day
Sponsors
British Heart Foundation
University of Newcastle Upon-Tyne
Newcastle-upon-Tyne Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with T2DM and CAS as defined below: * Clinical definitions * T2DM: Diagnosed according to the WHO criteria \[53\]. * CAD:Presence of any one of the following: Angina plus positive exercise tolerance test, enzyme and/or Q wave positive myocardial infarction, angiographic evidence ( \>50% stenosis of one vessel), percutaneous or surgical coronary revascularisation. * Aged between 18 and 75 * Provided written consent for participation in the trial prior to any study-specific procedures or requirements.
Exclusion criteria
* Contraindication to Clopidogrel * Smoking (current smokers and patients who quit smoking less than six months) * Malignancy(diagnosed or under investigation) * Haematological disorders (Anaemia, malignancy, bleeding disorders) * Women of child-bearing potential * Use of corticosteroids/other antithrombotic agents(warfarin) * Chronic liver disease (Cirrhosis, malignancy and patients with more than twice the upper limit of liver function tests) * Unable to consent. * Use of other investigational study drugs within 1 year prior to study entry * Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with T2DM and CAD with placebo | seven days |
Secondary
| Measure | Time frame |
|---|---|
| To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy | seven days |
| To characterise features in T2DM patients responsible for increased thrombogenicity | seven days |
Countries
United Kingdom
Outcome results
None listed