None listed
Conditions
Brief 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.
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 dila
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.
Sponsors
Pfizer Cardiovascular Lipid Research Grant
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
18 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 criteria
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.
Outcome results
None listed