The goal of this 2x2 factorial clinical trial is to test the efficacy of i) colchicine, and ii) thiamine in heart failure (HF) secondary to ischemic heart disease. The main questions it aims to answer are: * Does colchicine reduce the risk of cardiovascular (CV) death, a HF event, or an ischemic CV event * Does thiamine reduce the risk of cardiovascular (CV) death, or a HF event Participants will undergo the following procedures: * Run-in: All participants will receive colchicine 0.5 mg daily to assess drug tolerance over a 3-4 week period. * Randomization: If colchicine is tolerated during run-in, eligible participants will be randomized in a 2x2 factorial design to receive i) colchicine 0.5mg daily or placebo, and ii) thiamine 300mg daily or no thiamine. * Follow-up: Clinical outcomes, side effects, adverse events, and drug adherence will be captured during follow-up
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,500
Oral colchicine 0.5 mg daily
Placebo colchicine daily
Thiamine Mononitrate 300 mg daily
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
RECRUITINGColchicine arm: Time to first occurrence of a CV death, a HF event, MI, stroke, or arterial revascularization
Time frame: 3.5 years
Thiamine arm: Time to first occurrence of a CV death, or a HF event
Time frame: 3.5 years
Time to death
Time frame: 3.5 years
Time to first hospitalization
Time frame: 3.5 years
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