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RECRUITING
NCT05873881
PHASE3

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

Sponsor: Hamilton Health Sciences Corporation

View on ClinicalTrials.gov

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

DRUG

Colchicine 0.5 MG

Oral colchicine 0.5 mg daily

DRUG

Colchicine placebo

Placebo colchicine daily

DRUG

Thiamine Mononitrate 300 mg

Thiamine Mononitrate 300 mg daily

Locations (1)

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada