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NCT07362966
Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis
Conditions: Colchicine, Coronary Atherosclerosis Management, Clonal Hematopoiesis of Indeterminate Potential
Sex: All
Ages: 40 Years – 85 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 120
Sponsor: Shenyang Northern Hospital
Location: General Hospital of Northern Theater Command Shenyang Liaoning
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.
Eligibility Criteria
Inclusion Criteria:
1. Age 40-85 years;
2. Patients with recent hospitalization for documented ACS (the index event occurring 30-90 days before randomization) and meeting all of the following:
1. During the index hospitalization, patients underwent either PCI or diagnostic coronary angiography alone,
2. At least one non-culprit coronary lesion with 30%-70% diameter stenosis by visual estimation on coronary angiography,
3. Clinically stable throughout the screening period,
4. Receiving standard of care therapy for ACS in accordance with national guidelines,
5. Peripheral blood DNA available for targeted sequencing, with results demonstrating either TET2-CHIP or no CHIP-associated variants;
3. Written informed consent.
Exclusion Criteria:
1. Prior coronary artery bypass grafting (CABG) before documented ACS;
2. Other clinically significant cardiovascular diseases, including moderate-to-severe valvular heart disease (moderate or severe), heart failure (NYHA class III-IV), or atrial fibrillation;
3. Non-culprit coronary anatomy (e.g., marked tortuosity, bifurcation lesions, or small vessels \3 times the upper limit of normal range) at randomization;
6. Abnormal renal function (serum creatinine \>1.5 times the upper limit of normal range or estimated eGFR \
Source: ClinicalTrials.gov (NCT07362966). StuddyBuddy aggregates publicly available trial information.