Health TrialsbyHealthPanel

COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45+
SponsorHamilton Health Sciences Corporation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >/= 45 years

a prior history of CAD (defined as a history of myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, or non-invasive or invasive cardiac testing consistent with a diagnosis of CAD), and

determination of CAD to be the cause primary cause of HF based on local investigator assessment

New York Heart Association (NYHA) class II-IV symptoms

Disqualifiers

Female who is pregnant, breast-feeding, or of childbearing potential and not using an effective form of birth control*

Regular or required use colchicine or thiamine for other clinical indications.**

History of allergic reaction to colchicine or to thiamine; or current or planned use of cyclosporine, verapamil, diltiazem, azole antifungal, macrolide antibiotic (except azithromycin), or HIV protease inhibitor

Use of a ventricular assist device or prior heart transplant

Trial design

Design model

Factorial

Treatments tested in this trial

  • Colchicine 0.5 MG

    Drug

    Oral colchicine 0.5 mg daily

  • Colchicine placebo

    Drug

    Placebo colchicine daily

  • Thiamine Mononitrate 300 mg

    Drug

    Thiamine Mononitrate 300 mg daily

Treatment groups

2,500 Participants
are divided into 2 treatment groups
Group A: Colchicine versus placeboPlacebo comparator 2 interventions
Group B: Thiamine versus no thiamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Colchicine arm: Time to first occurrence of a CV death, a HF event, MI, stroke, or arterial revascularization

Time frame
3.5 years
2

Thiamine arm: Time to first occurrence of a CV death, or a HF event

Time frame
3.5 years

Secondary outcomes

1

Time to death

Time frame
3.5 years
2

Time to first hospitalization

Time frame
3.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

Population Health Research Institute

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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