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秋水仙碱对携带TET2-CHIP变异患者冠状动脉粥样硬化进展的影响

2026年9月30日 更新者：Han Yaling、Shenyang Northern Hospital

秋水仙碱对携带TET2-CHIP变异患者冠状动脉粥样硬化进展的影响：一项先导临床试验（COLCHIP-Pilot）

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

120

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Zaixin Jiang, MD, PhD
  • 电话号码：+8618646330195
  • 邮箱：jzxdr2013@163.com

学习地点

  • 中国
    • Liaoning
      • Shenyang、Liaoning、中国
        • 招聘中
        • General Hospital of Northern Theater Command
        • 首席研究员：
          • Yaling Han, MD, PhD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Colchicine with SoC therapy (TET2-CHIP group)

Participants with TET2-CHIP will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months.
药品：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.

其他：SoC therapy

SoC therapy
无干预：SoC therapy alone (TET2-CHIP group)

Participants with TET2-CHIP will receive SoC therapy alone (no colchicine) for 12 months.
实验性的：Colchicine with SoC therapy (non-CHIP group)

Participants without CHIP-associated variants will receive colchicine 0.5 mg orally once daily plus standard of care (SoC) therapy for 12 months.
药品：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.

其他：SoC therapy

SoC therapy
无干预：SoC therapy alone (non-CHIP group)

Participants without CHIP-associated variants will receive SoC therapy alone (no colchicine) for 12 months.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percent change in total plaque volume of coronary artery plaque
大体时间：Up to 12 months

Percent change in total plaque volume of coronary artery plaque measured by CCTA
Up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque
大体时间：Up to 12 months

Percent change in other plaques (calcified plaque, noncalcified plaque, low attenuation plaque, and fibrotic plaque) volume of coronary artery plaque measured by CCTA.
Up to 12 months
Change in levels of inflammatory biomarkers
大体时间：Up to 12 months

Change in levels of circulating IL-6, IL-1β, IL-18, hs-CRP, and S100A12.
Up to 12 months
Change in TET2-CHIP variant allele fraction at 6 months
大体时间：Up to 6 months

Change in TET2-CHIP variant allele fraction measured by next generation sequencing.
Up to 6 months
Change in TET2-CHIP variant allele fraction at 12 months
大体时间：Up to 12months

Change in TET2-CHIP variant allele fraction measured by next generation sequencing.
Up to 12months
Major adverse cardiovascular events (MACE)
大体时间：Up to 12 months

A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization.
Up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shenyang Northern Hospital

调查人员

  • 学习椅：Yaling Han, MD, PhD、The General Hospital of Northern Theater Command

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月8日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年1月15日

首先提交符合 QC 标准的

2026年1月22日

首次发布 (实际的)

2026年1月23日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PRECISE

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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