LoDoCo - VRIC Low Dose Colchicine in stable coronary artery disease, Vascular Reactivity and the Inflammatory Cascade.
The effect of low dose colchicine(1mg/dy) administered to patients with stable coronary artery disease compared with no treatment on brachial artery flow mediated dilation and blood inflammatory markers.
Pfizer Cardiovascular Lipid Research Grant
40 participants
Jan 1, 2010
Interventional
Conditions
Summary
The LoDoCo VRIC study aims to investigate the effect of low dose colchicine on inflammatory markers and coronary artery disease as measured by a surrogate marker, brachial artery flow mediated dilation in a stable coronary artery disease population.
Eligibility
Inclusion Criteria6
- to 80 years old.
- Male and female.
- History of proven coronary artery disease by coronary agnigraphy. (>50% stenosis of epicardial coronary artery or requirement for percutaneous coronary intervention)
- Stable for >1 month
- No significant co-morbidity that will affect followup.
- No contraindication to colchicine use.
Exclusion Criteria9
- Any patient who is not deemed to have stable coronary artery disease.
- Mild coronary artery disease.
- Advanced heart failure (New York Heart Association grade 3 or 4).
- Renal failure with creatnine clearance(<30ml/min/1.73m2).
- Known malignancy.
- Inflammatory bowel disease.
- Requirement for cyclosporine or other drugs that may interact with colchicine.
- Known sensitivity to colchicine.
- Pregnancy or contemplated pregnancy during the study period.
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Interventions
Patients are randomly assigned to treatment or control group initially and then cross over to the alternate group after a one month washout period. Colchicine 1mg/day oral tablets for three months on top of standard medical therapy will be administered while in the treatment group. Standard medical therapy will include any of the following and is at the discretion of the primary care physician: Statins, Angiotensin Converting Enzyme inhibitors, Beta Blockers and Aspirin. Flow mediated dilation testing is performed at baseline and after three months participation in both control and treatment arms.
Locations(1)
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ACTRN12610000397011