oDoCo - VRIC Low Dose Colchicine in stable coronary artery disease, Vascular Reactivity and the Inflammatory Cascade.
- Conditions
- Coronary Artery DiseaseCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12610000397011
- Lead Sponsor
- Pfizer Cardiovascular Lipid Research Grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To correlate high sensitivity C-reactive protein levels with changes in endothelial function as measured by brachial artery flow mediated dilation.[3 months. Baseline and 3 month measurement of flow mediated dilation.]
- Secondary Outcome Measures
Name Time Method To determine the effect of low dose colchicine on blood inflammatory cytokines (high sensitivity C-reactive protein, interleukin 1, interleukin 6, Tumor necrosis factor alpha and serum amyloid A) via the measurement of inflammatory cytokine levels after phlebotomy using automated analysis.[3 months. Baseline and 3 month measurement of inflammatory cytokines.]