Hamilton Health Sciences Corporation
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
Heart Failure
Colchicine 0.5 MG
Colchicine placebo
Thiamine Mononitrate 300 mg
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 2500 participants |
Masking : | Double |
Masking Description : | Factorial 1: Placebo controlled. Factorial 2: Prospective Randomized Open Blinded End-point (PROBE) design |
Primary Purpose : | Treatment |
Official Title : | COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease |
Actual Study Start Date : | January 29, 2024 |
Estimated Primary Completion Date : | June 2027 |
Estimated Study Completion Date : | June 2027 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Colchicine versus placebo Randomization to colchicine or placebo |
Drug: Colchicine 0.5 MG |
Experimental: Thiamine versus no thiamine Randomization to thiamine or to no thiamine in a PROBE design |
Drug: Colchicine placebo |
Ages Eligible for Study: | 45 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, Say xa