Colchicine for Clogged Heart Arteries in People With TET2 Blood Cell Mutations
Tests colchicine in stable people after an acute heart event, with TET2 clonal hematopoiesis.
Plain-language title generated from the registry record
Registry title: Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis
Key facts
- Where
- Shenyang, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40-85 who had a heart attack or similar event (ACS) 30-90 days ago and are now stable. It tests whether colchicine works differently in people with TET2 clonal hematopoiesis (TET2-CHIP).
- Age
- 40-85 years
- Sex
- Men and women can join.
- Disease stage
- Hospitalized for ACS 30-90 days before joining, now clinically stable, with at least one other heart artery narrowing of 30%-70%.
- Earlier treatment
- Must be getting standard ACS treatment. Colchicine within 30 days before joining is not allowed.
- Biomarker or test result
- Blood DNA sequencing must show either TET2-CHIP or no CHIP-associated variants.
Main reasons for not taking part
- Earlier bypass surgery (CABG) before the ACS, or planned PCI or CABG
- Heart failure (NYHA class III-IV), atrial fibrillation or moderate-to-severe valve disease
- Serious liver, kidney or blood count problems
- Pregnancy or breastfeeding, or allergy or intolerance to colchicine
- History of cancer or of a stem-cell or organ transplant
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Source: NCT07362966, who can take part
Where in China
- General Hospital of Northern Theater CommandShenyang, ChinaContact: Zaixin Jiang, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shenyang Northern Hospital
- Trial code
- NCT07362966
- Record updated
- 1 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Prior coronary artery bypass grafting (CABG) before documented ACS; Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications; Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs; Significant radiation exposure (≥40 mSv) within the past 12 months; Other clinically significant cardiovascular diseases, including moderate-to-severe valvular heart disease (moderate or severe), heart failure (NYHA class III-IV), or atrial fibrillation; Inflammatory bowel disease (Crohn's or ulcerative colitis) or active diarrhea; Symptomatic peripheral neuropathy, pre-existing progressive neuromuscular disease or creatine kinase (CK) level > 3 times the upper limit of normal range as measured within the past 30 days and determined to be non-transient through repeat testing; Any contraindication, known allergy or intolerance to colchicine; Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics; History of malignancy (hematologic or solid-tumor); History of transplantation (hematopoietic stem cell or solid-organ); Known hypersensitivity to iodinated contrast media or uncontrolled active hyperthyroidism; Abnormal liver function (ALT >3 times the upper limit of normal range) at randomization; Abnormal renal function (serum creatinine >1.5 times the upper limit of normal range or estimated eGFR <45 mL/min/1.73 m²) at randomization; Hematologic abnormalities: anemia (hemoglobin <100g/L), thrombocytopenia (platelet count <100×109/L) or leukopenia (white blood cell <3×109/L) at randomization; 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; Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception; Current enrollment in another clinical trial; A predicted life expectancy < 1 year; Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.