None listed
Conditions
Brief summary
Prospective Randomized Observer Blinded Evaluation trial to determine the effect of adding colchicine 0.5mg/d to usual medical therapy in patients with proven coronary disease on the risk of future coronary events and stroke [unrelated to atrial fibrillation or intra-cranial hemorrhage]
Interventions
Colchicine 0.5mg/day orally for duration of study period unless side effects occur [minimum of 2 years]
Sponsors
Mark Nidorf
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Angiographic proof of coronary disease Clinically stable for >6months Coronary Artery Bypass Grafting [CABG] more than 10 years ago or CABG at any time if the patient had subesquently had recurrent angina and angiographic evidence of blocked grafts or progressive native coronary disease requiring intervention with angioplasty Willing to be randomised Likely to be compliant
Exclusion criteria
Any clinically significant co-morbidity Clinical instability within prior 6 months CABG<10 years ago unless intervention has been required Unwilling to enrole or uncertainty re compliance Already on long-term colchicine for unrelated condition Known sensitivity to colchicine Pregnancy
Outcome results
None listed