Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis : a Pilot Clinical Trial (PRECISE)
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.
• 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.