None listed
Conditions
Brief summary
The COPS trial is a prospective multicentre randomised study to examine the effect of adding low-dose colchicine to standard medical therapy in patients who have had a heart attack. A total of 1009 participants will be recruited from hospitals across Australia over the study period. Participants will be randomised to either (a) standard medical therapy or (b) standard medical therapy plus low-dose oral colchicine. Participants will be followed up for 12 months for predefined major adverse cardiovascular outcomes via telephone interviews. We hypothesise that the addition of colchicine to standard medical therapy will reduce long-term major adverse cardiovascular events in patients who have had a heart attack.
Interventions
Participants will receive oral colchicine 0.5mg tablets twice daily for 1 month followed by oral colchicine 0.5mg once daily for 11 months, in addition to the standard medical therapy for ischaemic heart disease.
Medication adherence will be assessed indirectly by pill counts. Participants will be asked to count the number of pills remain in their medication bottles during scheduled telephone interviews.
Sponsors
St. Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
- Age between 18 to 85 years old - Patients who are admitted to the hospital with acute coronary syndromes (also known as a heart attack) - defined by elevated troponin with ischaemic symptoms or ECG changes - Presence of coronary artery disease on coronary angiogram – defined by >30% luminal stenosis in epicardial vessel of >2.5mm luminal diameter, which is managed with PCI or medical therapy - Able to provide written informed consent
Exclusion criteria
- Coronary artery disease requiring surgical revascularization - Pre-existing long-term colchicine use for other medical conditions - Pre-existing, or plan for, administration of other immunosuppressant therapy - Severe liver impairment – defined by elevated serum ALT and/or AST levels twice the upper limit of normal AND total serum bilirubin level twice the upper limit of normal OR coagulopathy (INR>1.5) - Severe renal insufficiency – defined by eGFR<30mL/min/1.73m2 - Pre-existing use of strong CYP3A4 or P-glycoprotein inhibitors (eg. cyclosporine, antiretroviral drugs, antifungals, erythromycin and clarithromycin) and no other alternative medical therapy can be used - Known active malignancy - Known allergy or hypersensitivity to colchicine - Pregnant and lactating woman or woman with childbearing potential without effective birth control methods
Outcome results
None listed