Effect of Colchicine on Progression of Coronary Atherosclerosis in Patients With TET2-CHIP Variant (NCT07362966) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effect of Colchicine on Progression of Coronary Atherosclerosis in Patients With TET2-CHIP Variant
China120 participantsStarted 2026-02-24
Plain-language 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.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Prior PCI or coronary artery bypass grafting (CABG) before documented ACS;
What they're measuring
1
Percent change in total plaque volume of coronary artery plaque
. 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;