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COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease
Sponsor: Hamilton Health Sciences Corporation
Summary
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
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2500
Start Date
2024-01-29
Completion Date
2027-06
Last Updated
2025-06-19
Healthy Volunteers
No
Conditions
Interventions
Colchicine 0.5 MG
Oral colchicine 0.5 mg daily
Colchicine placebo
Placebo colchicine daily
Thiamine Mononitrate 300 mg
Thiamine Mononitrate 300 mg daily
Locations (1)
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada