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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 40 to 85

Precision colchicine to target atherosclerosis in people with TET2-CHIP after ACS

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

Run by Shenyang Northern Hospital · NCT07362966 · Data updated 2026-11-12

This study tests whether including colchicine helps post-ACS patients, guided by TET2-CHIP status, to reduce plaque growth.

More Clonal Hematopoiesis of Indeterminate Potential trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages40 Years to 85 Years
SexAll
Enrollment120 (estimated)
SponsorShenyang Northern Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Shenyang, Liaoning)
StatusRecruiting
StartedJune 8, 2026
Main results expectedDecember 1, 2027
Study endsDecember 1, 2027
Registry record updatedOctober 1, 2026
Trial IDNCT07362966 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 40–85 who recently had ACS (30–90 days prior), have non-culprit lesions 30–70% stenosed, and have detectable TET2-CHIP or no CHIP on sequencing, with consent and adherence to standard ACS care.

Probably not a fit

Patients without CHIP or those unlikely to tolerate colchicine or adhere to follow-up may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized pilot trial enrolling 120 adults who recently had an acute coronary syndrome. Participants are stratified by TET2-CHIP status and randomized to receive colchicine 0.5 mg daily plus standard care or standard care alone for 12 months; all participants undergo baseline and follow-up imaging and biomarker assessments. The primary endpoint is the change in total non-culprit plaque volume from baseline to 12 months measured by coronary CT angiography. Secondary endpoints include changes in other plaque types and safety measures. The study aims to see if CHIP status can guide precision use of colchicine and to collect data to inform larger future trials.

Why it matters

Potential benefit: If successful, patients with TET2-CHIP could receive more tailored anti-inflammatory therapy to slow plaque progression after ACS.

How similar studies have gone: Previous inflammatory approaches in post-ACS patients have shown mixed results; this study is novel in using CHIP status to guide therapy.

Who can join: the full rules

Show full inclusion / exclusion 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 \<1.5 mm in diameter) deemed to preclude plaque assessment by CCTA;
4. Planned PCI or CABG;
5. Abnormal liver function (ALT \>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 \<45 mL/min/1.73 m²) at randomization;
7. Hematologic abnormalities: anemia (hemoglobin \<100g/L), thrombocytopenia (platelet count \<100×109/L) or leukopenia (white blood cell \<3×109/L) at randomization;
8. Inflammatory bowel disease (Crohn's or ulcerative colitis) or active diarrhea;
9. 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;
10. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception;
11. Any contraindication, known allergy or intolerance to colchicine;
12. Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications;
13. Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics;
14. Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;
15. History of malignancy (hematologic or solid-tumor);
16. History of transplantation (hematopoietic stem cell or solid-organ);
17. Significant radiation exposure (≥40 mSv) within the past 12 months;
18. Known hypersensitivity to iodinated contrast media or uncontrolled active hyperthyroidism;
19. Current enrollment in another clinical trial;
20. A predicted life expectancy \< 1 year;
21. Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.

Where it's running

  • General Hospital of Northern Theater Command
    Shenyang, Liaoning, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.