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COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

NCT05873881 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2025-06-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Philip G Joseph, M.D. · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05873881 on ClinicalTrials.gov