NCT05873881

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: Hamilton Health Sciences Corporation · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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

Conditions

• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-29
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-05-24
• Last updated: 2025-06-19

Locations

1 site across 1 country: Canada