Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-85
SponsorShenyang Northern Hospital

About this trial

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 criteria

Qualifiers

Age 40-85 years;

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,

Disqualifiers

Prior coronary artery bypass grafting (CABG) before documented ACS;

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;

Trial design

Treatments tested in this trial

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

Treatment groups

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators