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Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis

ConditionsColchicineCoronary Atherosclerosis ManagementClonal Hematopoiesis of Indeterminate Potential
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-85
SponsorShenyang Northern Hospital

About this trial

This study aims to investigate whether TET2-associated clonal hematopoiesis of indeterminate potential (TET2-CHIP) can serve as a biomarker to guide precision use of colchicine in a population of clinically stable post-ACS patients receiving standard of care (SoC) therapy. Specifically, we will evaluate whether TET2-CHIP status predicts a differential response to colchicine. As a pilot study, it also aims to provide detailed data supporting design of further trial, such as sample size calculating, endpoint optimizing, etc.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40-85 years;

During the index hospitalization, patients underwent either PCI or diagnostic coronary angiography alone,

At least one non-culprit coronary lesion with 30%-70% diameter stenosis by visual estimation on coronary angiography,

Clinically stable throughout the screening period,

Disqualifiers

Prior coronary artery bypass grafting (CABG) before documented ACS;

Other clinically significant cardiovascular diseases, including moderate-to-severe valvular heart disease (moderate or severe), heart failure (NYHA class III-IV), or atrial fibrillation;

Non-culprit coronary anatomy (e.g., marked tortuosity, bifurcation lesions, or small vessels <1.5 mm in diameter) deemed to preclude plaque assessment by CCTA;

Planned PCI or CABG;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Colchicine 0.5 mg orally once daily for 12 months.

    Drug

    SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines.

  • SoC therapy

    Other intervention

    SoC therapy

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Colchicine with SoC therapy (TET2-CHIP group)Experimental treatment 2 interventions
Group B: SoC therapy alone (TET2-CHIP group)No intervention 0 interventions
Group C: Colchicine with SoC therapy (non-CHIP group)Experimental treatment 2 interventions
Group D: SoC therapy alone (non-CHIP group)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percent change in total plaque volume of coronary artery plaque

Percent change in total plaque volume of coronary artery plaque measured by CCTA

Time frame
Up to 12 months

Secondary outcomes

1

Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque

Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque measured by CCTA.

Time frame
Up to 12 months
2

Change in levels of inflammatory biomarkers

Change in levels of circulating IL-6, IL-1β, IL-18, hs-CRP, and S100A12.

Time frame
Up to 12 months
3

Change in TET2-CHIP variant allele fraction at 6 months

Change in TET2-CHIP variant allele fraction measured by next generation sequencing.

Time frame
Up to 6 months
4

Change in TET2-CHIP variant allele fraction at 12 months

Change in TET2-CHIP variant allele fraction measured by next generation sequencing.

Time frame
Up to 12months

Other outcomes

Sponsors and contacts

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

Shenyang Northern Hospital

Lead sponsor

Source ClinicalTrials.gov
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