TrialPhase 4Recruiting
Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis
Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis : a Pilot Clinical Trial (PRECISE)
- Sponsor
- Shenyang Northern Hospital (Academic or other)
- Enrolment
- 120 planned
- Conditions
- Colchicine; Coronary Atherosclerosis Management; Clonal Hematopoiesis of Indeterminate Potential
- Interventions
- Colchicine 0.5 mg orally once daily for 12 months.; SoC therapy
- Ages
- adults, older adults
- Registry
- NCT07362966
From the registry
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.
Primary outcomes
- Percent change in total plaque volume of coronary artery plaque