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Recruiting Phase 4

Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis

NCT07362966 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2026-06-08
Last updated
2026-10-01

Condition(s) studied

ColchicineCoronary Atherosclerosis ManagementClonal Hematopoiesis of Indeterminate Potential

Investigational drug(s) / intervention(s)

Colchicine 0.5 mg orally once daily for 12 months.SoC therapy

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.

SoC therapy: SoC therapy

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 40-85 years; 2. Patients with recent hospitalization for documented ACS (the index event occurring 30-90 days before randomization) and meeting all of the following: 1. During the index hospitalization, patients underwent either PCI or diagnostic coronary angiography alone, 2. At least one non-culprit coronary lesion with 30%-70% diameter stenosis by visual estimation on coronary angiography, 3. Clinically stable throughout the screening period, 4. Receiving standard of care therapy for ACS in accordance with national guidelines, 5. Peripheral blood DNA available for targeted sequencing, with results demonstrating either TET2-CHIP or no CHIP-associated variants; 3. Written informed consent. Exclusion Criteria: 1. Prior coronary artery bypass grafting (CABG) before documented ACS; 2. Other clinically significant cardiovascular diseases, including moderate-to-severe valvular heart disease (moderate or severe), heart failure (NYHA class III-IV), or atrial fibrillation; 3. 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; 4. Planned PCI or CABG; 5. Abnormal liver function (ALT \>3 times the upper limit of normal range) at randomization; 6. 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; 7. Hematologic abnormalities: anemia (hemoglobin \<100g/L), thrombocytopenia (platelet count \<100×109/L) or leukopenia (white blood cell \<3×109/L) at randomization; 8. Inflammatory bowel disease (Crohn's or ulcerative colitis) or active diarrhea; 9. 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; 10. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception; 11. Any contraindication, known allergy or intolerance to colchicine; 12. Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications; 13. Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics; 14. Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs; 15. History of malignancy (hematologic or solid-tumor); 16. History of transplantation (hematopoietic stem cell or solid-organ); 17. Significant radiation exposure (≥40 mSv) within the past 12 months; 18. Known hypersensitivity to iodinated contrast media or uncontrolled active hyperthyroidism; 19. Current enrollment in another clinical trial; 20. A predicted life expectancy \< 1 year; 21. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.

Primary outcome measure(s)

  • Percent change in total plaque volume of coronary artery plaque — Up to 12 months
    Percent change in total plaque volume of coronary artery plaque measured by CCTA

Trial sites (1)

FacilityCityRegionStatus
General Hospital of Northern Theater Command Shenyang Liaoning Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07362966 on ClinicalTrials.gov ↗ ← All trials in China