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

NCT07362966 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: COLCHIP-Pilot
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colchicine; Coronary Atherosclerosis Management; Clonal Hematopoiesis of Indeterminate Potential

Outcome Measures

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

  Up to 12 months

Secondary Outcomes (5)

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

  Up to 12 months

• Change in levels of inflammatory biomarkers

  Up to 12 months

• Change in TET2-CHIP variant allele fraction at 6 months

  Up to 6 months

• Change in TET2-CHIP variant allele fraction at 12 months

  Up to 12months

• Major adverse cardiovascular events (MACE)

  Up to 12 months

Study Arms (4)

Colchicine with SoC therapy (TET2-CHIP group)

EXPERIMENTAL

Participants with TET2-CHIP will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months.

Drug: Colchicine 0.5 mg orally once daily for 12 months.; Other: SoC therapy

SoC therapy alone (TET2-CHIP group)

NO INTERVENTION

Participants with TET2-CHIP will receive SoC therapy alone (no colchicine) for 12 months.

Colchicine with SoC therapy (non-CHIP group)

EXPERIMENTAL

Participants without CHIP-associated variants will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months.

Drug: Colchicine 0.5 mg orally once daily for 12 months.; Other: SoC therapy

SoC therapy alone (non-CHIP group)

NO INTERVENTION

Participants without CHIP-associated variants will receive SoC therapy alone (no colchicine) for 12 months.

Interventions

SoC therapy OTHER

SoC therapy

Colchicine with SoC therapy (TET2-CHIP group); Colchicine with SoC therapy (non-CHIP group)

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.

Colchicine with SoC therapy (TET2-CHIP group); Colchicine with SoC therapy (non-CHIP group)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-85 years;
• Patients with recent hospitalization for documented ACS (the index event occurring 30-90 days before randomization) and meeting all of the following:
• 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,
• Receiving standard of care therapy for ACS in accordance with national guidelines,
• Peripheral blood DNA available for targeted sequencing, with results demonstrating either TET2-CHIP or no CHIP-associated variants;
• Written informed consent.

You may not qualify if:

• Prior PCI or 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;
• Abnormal liver function (ALT \>3 times the upper limit of normal range) at randomization;
• Abnormal renal function (serum creatinine \>1.5 times the upper limit of normal range or estimated eGFR \<45 mL/min/1.73 m²) at randomization;
• Hematologic abnormalities: anemia (hemoglobin \<100g/L), thrombocytopenia (platelet count \<100×109/L) or leukopenia (white blood cell \<3×109/L) at randomization;
• Inflammatory bowel disease (Crohn's or ulcerative colitis) or active diarrhea;
• Symptomatic peripheral neuropathy, pre-existing progressive neuromuscular disease or creatine kinase (CK) level \> 3 times the upper limit of normal range as measured within the past 30 days and determined to be non-transient through repeat testing;
• Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception;
• Any contraindication, known allergy or intolerance to colchicine;
• Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications;
• Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics;
• Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;
• History of malignancy (hematologic or solid-tumor);

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Yaling Han, MD, PhD

  The General Hospital of Northern Theater Command

  STUDY CHAIR

Central Study Contacts

Zaixin Jiang, MD, PhD

CONTACT

+8618646330195; jzxdr2013@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)