None listed
Conditions
Brief summary
The primary objective of this study is to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of the composite of cardiovascular death, myocardial infarction, ischemic stroke or ischemia-driven coronary revascularisation.
Interventions
Colchicine 0.5mg tablet taken orally each day for the duration of the trial, It is expected that some participants randomized earlier in the trial will receive treatment for up to 5 years, whereas others randomized later in the trial will be on the trial medication for a minimum of 1 year. LoDoCo2 is an event driven intention to treat trial: participation continues until the requisite number of primary events have occurred and with the requirement of a minimal follow-up of 1 year.
Adherence will
Colchicine 0.5mg tablet taken orally each day for the duration of the trial, It is expected that some participants randomized earlier in the trial will receive treatment for up to 5 years, whereas others randomized later in the trial will be on the trial medication for a minimum of 1 year. LoDoCo2 is an event driven intention to treat trial: participation continues until the requisite number of primary events have occurred and with the requirement of a minimal follow-up of 1 year. Adherence will be determined by questionnaire every 6 months at the time of collection of the new supply of the trial medication, No serum levels of colchicine metabolites are being measured
Sponsors
Heart Research Institute, Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
Patients with coronary heart disease diagnosed by coronary angiography or CT coronary angiogram who are clinically stable [no cardiovascular related hospital admission in the prior 6 months] and Patients with CABG>10 years ago, unless evidence of graft failure or the need for angioplasty since surgery
Exclusion criteria
1] Serious Non-Cardiac Co-morbidity; including prior history of myopathy, leucopenia or thrombocytopenia , renal dysfunction with eGFR <50mL/min or serum Creatinine>150mmol/l, advanced liver disease, severe intestinal disease, advanced cancer 2] history of noncompliance with medical therapy or known to be poor clinic attendee, 3] A need for regular drugs known to be potent CYP inhibitors (e.g., ketaconazole or clarithromycin), 4] Other advanced Cardiac Disease; Advanced valvular heart disease, Severe LV dysfunction or symptomatic heart failure or Severe Pulmonary hypertension, 5] Women of child bearing age; 6] Current on-going use of long term colchicine therapy for any other reason, 6] Known intolerance to colchicine, 7] Enrollment in a competing trial, 8] Unwilling or unable to be consented for inclusion into the study for any reason.
Outcome results
None listed