Pilot Study of Colchicine Treatment for Heart Artery Disease in Patients with TET2 Clonal Hematopoiesis After Acute Coronary Syndrome

What this Trial Is About

This research aims to study whether TET2-associated clonal hematopoiesis of indeterminate potential TET2-CHIP can be used as a biomarker to guide the targeted use of colchicine in patients who are clinically stable after acute coronary syndrome ACS and receiving standard care. The study focuses on whether TET2-CHIP status influences how patients respond to colchicine, and as a pilot trial, it seeks to provide data for designing future studies, including sample size and endpoint optimization. Participants will be divided into two groups based on CHIP variant status those with TET2-CHIP and those without. Each group will be randomized to receive either colchicine 0.5 mg daily plus standard of care SoC therapy or SoC alone for 12 months. SoC includes treatments such as lipid lowering, anti-platelet therapy, antihypertensives, and beta blockers, alongside instructions for a heart-healthy diet and regular exercise. Baseline and 12-month coronary CT angiography CCTA will be performed to assess coronary plaque. Participants will attend visits at months 0, 1, 3, 6, 9, and 12, undergoing inflammatory biomarker tests and CHIP variant sequencing. The primary outcome is the percent change in total plaque volume of non-culprit coronary lesions over 12 months. Secondary measures include changes in various plaque types, inflammatory biomarkers, TET2-CHIP variant allele fraction, and major cardiovascular events. Safety and effectiveness will be monitored throughout the study duration.

Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis