Coronary Artery Disease Clinical Trial
Official title:
A Randomised Placebo-controlled Trial of Metformin on Progression of Carotid Atherosclerosis in Non-diabetic Patients With Cardiovascular Disease Treated With Conventional Risk Reducing Agents
Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary
heart disease and on standard cardiovascular risk reducing agents including statins will
have a beneficial impact on carotid artery atherosclerosis compared to placebo.
Rationale: Once subjects have a heart attack, they remain at much higher than average risk
of another heart attack and stroke, despite the best current therapies to lower their
cholesterol and blood pressure and thin their blood. Many subjects with heart disease also
have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There
is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk
of future heart attacks in diabetic patients. However, whether metformin further reduces the
risk of heart disease beyond established treatments in people without diabetes is unknown.
Method: The investigators will test the ability metformin, a drug with proven safety, to
slow the progression of furring up (known as atherosclerosis) of blood vessels in
non-diabetic subjects with heart disease. This will be achieved by treating 2 groups of
subjects with metformin and placebo pills respectively. To measure atherosclerosis, the
investigators will carry out ultrasound scans of the big blood vessels in the neck at the
start of the study, after 1 year and after 1.5 years of therapy.The investigators will then
be able to assess whether metformin has had a beneficial impact.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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