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New treatment option for Colchicine
Official title Precision Colchicine Intervention to Suppress Atherosclerosis in TET2 Clonal Hematopoiesis
ClinicalTrials.gov ID: NCT07362966
What this study is testing
What is Colchicine 0.5 mg orally once daily for 12 months.?
Colchicine 0.5 mg orally once daily for 12 months. is an investigational medicine, given as an once-daily, being studied as a potential treatment for colchicine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- 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,
You likely can't join if
- 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...
- Non-culprit coronary anatomy (e.g., marked tortuosity, bifurcation lesions, or small vessels \<1.5 mm in diameter) deemed to preclude plaque...
- 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;
See the full eligibility criteria
- 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.
- 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;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.