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Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05873881
Study type Interventional
Source Hamilton Health Sciences Corporation
Contact Philip G Joseph, M.D.
Phone 905-521-2100
Email philip.joseph@phri.ca
Status Recruiting
Phase Phase 3
Start date January 29, 2024
Completion date June 2027

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