NCT07362966

Effect of Colchicine on Progression of Coronary Atherosclerosis in Patients With TET2-CHIP Variant

Effect of Colchicine on Progression of Coronary Atherosclerosis in Patients With TET2-CHIP Variant: a Pilot Clinical Trial (COLCHIP-Pilot)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shenyang Northern Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

COLCHIP-Pilot is a single-center, prospective, randomized, open-label, assessor-blinded pilot trial. A total of 120 patients will be enrolled and stratified by CHIP variant status into a TET2-CHIP group or a non-CHIP group. TET2-CHIP group (N = 60): Participants will be randomized (1:1) to colchicine 0.5 mg once daily plus SoC therapy (n = 30) or SoC therapy alone (control; n = 30). Non-CHIP group (N = 60): Participants will be randomized (1:1) to colchicine 0.5 mg once daily plus SoC therapy (n = 30) or SoC therapy alone (control; n = 30). SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines. Patients should also be instructed to follow heart healthy (low fat) diet and regular exercise program. The index qualifying ACS must have occurred at least 30 days and no more than 90 days prior to randomization. Baseline assessment for all participants will include coronary CT angiography (CCTA) using photon-counting detector CT (PCD-CT), inflammatory biomarkers testing and CHIP variant sequencing. After randomization, participants will have visits at Month 0, 1, 3, 6, 9, and 12. Repeat CCTA for the assessment of coronary plaque will occur during the Month 12 visit. The primary endpoint is the percent change in total plaque volume in non-culprit coronary lesion from baseline to Month 12, measured by CCTA. Secondary endpoints include the percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque from baseline to Month 12; change in levels of inflammatory biomarkers (IL-6, IL-1β, IL-18, hs-CRP, and S100A12); change in the TET2-CHIP variant allele fraction; and major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization. Participants will be followed for 12 months.

Conditions

• Colchicine
• Coronary Atherosclerosis Management
• Clonal Hematopoiesis of Indeterminate Potential

Interventions

Type	Name	Description
DRUG	Colchicine 0.5 mg orally once daily for 12 months.	SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines.
OTHER	SoC therapy	SoC therapy

Timeline

• Start date: 2026-02-24
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: China