ColchicinePhase 4NCT07362966
Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis
A Phase 4 study testing Colchicine 0.5 mg orally once daily for 12 months. and SoC therapy in people with Colchicine and Coronary Atherosclerosis Management, run by Shenyang Northern Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Colchicine, Coronary Atherosclerosis Management, Clonal Hematopoiesis of Indeterminate Potential
- What is being tested?
- Colchicine 0.5 mg orally once daily for 12 months. and SoC therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2026to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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;
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- Hematologic abnormalities: anemia (hemoglobin <100g/L), thrombocytopenia (platelet count <100×109/L) or leukopenia (white blood cell <3×109/L) at randomization;
- 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;
- Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception;
- Any contraindication, known allergy or intolerance to colchicine;
- Colchicine use within 30 days prior to randomization, or planned colchicine therapy for other indications;
- Current or planned use of any of cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics;
- Existing or planned treatment with other anti-inflammatory or immunosuppressive drugs;
- History of malignancy (hematologic or solid-tumor);
- History of transplantation (hematopoietic stem cell or solid-organ);
- Significant radiation exposure (≥40 mSv) within the past 12 months;
- Known hypersensitivity to iodinated contrast media or uncontrolled active hyperthyroidism;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning
Zaixin Jiang, MD, PhD, +8618646330195, jzxdr2013@163.com
Yaling Han, MD, PhD
About this study
Official title: 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.
Read the detailed description
This is a single-center, prospective, randomized, open-label, assessor-blinded pilot trial. A total of 120 patients will be enrolled and stratified by CHIP variant status into a TET2-CHIP group or a non-CHIP group. TET2-CHIP group (N = 60): Participants will be randomized (1:1) to colchicine 0.5 mg once daily plus SoC therapy (n = 30) or SoC therapy alone (control; n = 30). Non-CHIP group (N = 60): Participants will be randomized (1:1) to colchicine 0.5 mg once daily plus SoC therapy (n = 30) or SoC therapy alone (control; n = 30). SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines. Patients should also be instructed to follow heart healthy (low fat) diet and regular exercise program. The index qualifying ACS must have occurred at least 30 days and no more than 90 days prior to randomization.
Baseline assessment for all participants will include coronary CT angiography (CCTA) using photon-counting detector CT (PCD-CT), inflammatory biomarkers testing and CHIP variant sequencing. After randomization, participants will have visits at Month 0, 1, 3, 6, 9, and 12. Repeat CCTA for the assessment of coronary plaque will occur during the Month 12 visit. The primary endpoint is the percent change in total plaque volume in non-culprit coronary lesion from baseline to Month 12, measured by CCTA. Secondary endpoints include the percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque from baseline to Month 12; change in levels of inflammatory biomarkers (IL-6, IL-1β, IL-18, hs-CRP, and S100A12); change in the TET2-CHIP variant allele fraction; and major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization. Participants will be followed for 12 months.
- Conditions
- Colchicine, Coronary Atherosclerosis Management, Clonal Hematopoiesis of Indeterminate Potential
- Being tested
- Colchicine 0.5 mg orally once daily for 12 months., SoC therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 mg orally once daily for 12 months.Drug
SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines.
SoC therapyOther
SoC therapy
| Study group | Role | What they receive |
|---|---|---|
| Colchicine with SoC therapy (TET2-CHIP group) | Experimental | Participants with TET2-CHIP will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months. Receives: Drug: Colchicine 0.5 mg orally once daily for 12 months.; Other: SoC therapy |
| SoC therapy alone (TET2-CHIP group) | No intervention | Participants with TET2-CHIP will receive SoC therapy alone (no colchicine) for 12 months. |
| Colchicine with SoC therapy (non-CHIP group) | Experimental | Participants without CHIP-associated variants will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months. Receives: Drug: Colchicine 0.5 mg orally once daily for 12 months.; Other: SoC therapy |
| SoC therapy alone (non-CHIP group) | No intervention | Participants without CHIP-associated variants will receive SoC therapy alone (no colchicine) for 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in total plaque volume of coronary artery plaque
Percent change in total plaque volume of coronary artery plaque measured by CCTA
Measured: Up to 12 months
Secondary outcomes (5)
Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque
Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque measured by CCTA.
Measured: Up to 12 months
Change in levels of inflammatory biomarkers
Change in levels of circulating IL-6, IL-1β, IL-18, hs-CRP, and S100A12.
Measured: Up to 12 months
Change in TET2-CHIP variant allele fraction at 6 months
Change in TET2-CHIP variant allele fraction measured by next generation sequencing.
Measured: Up to 6 months
Change in TET2-CHIP variant allele fraction at 12 months
Change in TET2-CHIP variant allele fraction measured by next generation sequencing.
Measured: Up to 12months
Major adverse cardiovascular events (MACE)
A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start8 Jun 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColchicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, MD, PhD, Study chair, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362966
- Sponsor's protocol ID
- PRECISE
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis : a Pilot Clinical Trial (PRECISE)
- ClinicalTrials.gov ID
- NCT07362966
- Acronym / sponsor ID
- PRECISE
- Conditions
- Colchicine, Coronary Atherosclerosis Management, Clonal Hematopoiesis of Indeterminate Potential
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, prospective, randomized, open-label, assessor-blinded pilot trial. A total of 120 patients will be enrolled and stratified by CHIP variant status into a TET2-CHIP group or a non-CHIP group. TET2-CHIP group (N = 60): Participants will be randomized (1:1) to colchicine 0.5 mg once daily plus SoC therapy (n = 30) or SoC therapy alone (control; n = 30). Non-CHIP group (N = 60): Participants will be randomized (1:1) to colchicine 0.5 mg once daily plus SoC therapy (n = 30) or SoC therapy alone (control; n = 30). SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines. Patients should also be instructed to follow heart healthy (low fat) diet and regular exercise program. The index qualifying ACS must have occurred at least 30 days and no more than 90 days prior to randomization.
Baseline assessment for all participants will include coronary CT angiography (CCTA) using photon-counting detector CT (PCD-CT), inflammatory biomarkers testing and CHIP variant sequencing. After randomization, participants will have visits at Month 0, 1, 3, 6, 9, and 12. Repeat CCTA for the assessment of coronary plaque will occur during the Month 12 visit. The primary endpoint is the percent change in total plaque volume in non-culprit coronary lesion from baseline to Month 12, measured by CCTA. Secondary endpoints include the percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque from baseline to Month 12; change in levels of inflammatory biomarkers (IL-6, IL-1β, IL-18, hs-CRP, and S100A12); change in the TET2-CHIP variant allele fraction; and major adverse cardiovascular events (MACE), defined as a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization. Participants will be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Colchicine with SoC therapy (TET2-CHIP group) | Experimental | Drug: Colchicine 0.5 mg orally once daily for 12 months., Other: SoC therapyParticipants with TET2-CHIP will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months. |
| SoC therapy alone (TET2-CHIP group) | No intervention | –Participants with TET2-CHIP will receive SoC therapy alone (no colchicine) for 12 months. |
| Colchicine with SoC therapy (non-CHIP group) | Experimental | Drug: Colchicine 0.5 mg orally once daily for 12 months., Other: SoC therapyParticipants without CHIP-associated variants will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months. |
| SoC therapy alone (non-CHIP group) | No intervention | –Participants without CHIP-associated variants will receive SoC therapy alone (no colchicine) for 12 months. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Written informed consent.
Key exclusion criteria (21 listed)
- 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;
- Abnormal liver function (ALT >3 times the upper limit of normal range) at randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 mg orally once daily for 12 months.SoC therapy includes but is not limited to appropriate lipid lowering, anti-platelet therapy, anti-hypertensive and beta blockers as defined by local guidelines. | Drug | Colchicine with SoC therapy (TET2-CHIP group), Colchicine with SoC therapy (non-CHIP group) |
| SoC therapySoC therapy | Other | Colchicine with SoC therapy (TET2-CHIP group), Colchicine with SoC therapy (non-CHIP group) |
Primary outcome
Percent change in total plaque volume of coronary artery plaque
Time frame: Up to 12 months
Percent change in total plaque volume of coronary artery plaque measured by CCTA
5 secondary outcomes
Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque
Time frame: Up to 12 months
Change in levels of inflammatory biomarkers
Time frame: Up to 12 months
Change in TET2-CHIP variant allele fraction at 6 months
Time frame: Up to 6 months
Change in TET2-CHIP variant allele fraction at 12 months
Time frame: Up to 12months
Major adverse cardiovascular events (MACE)
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaling Han, MD, PhD study chair
The General Hospital of Northern Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine 0.5 mg orally once daily for 12 months. and SoC therapy in people with Colchicine and Coronary Atherosclerosis Management, run by Shenyang Northern Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zaixin Jiang, MD, PhD (+8618646330195, jzxdr2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in total plaque volume of coronary artery plaque (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.