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Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)

2026年10月30日 更新者：Wenbin Zhang、Sir Run Run Shaw Hospital

Colchicine Titration Guided by Hs-CRP Targets on Cardiovascular Events in Very-High-Risk Coronary Heart Disease Patients After PCI: A Multicenter, Randomized, Open-Label, Noninferiority Trial

This multicenter, randomized, open-label, noninferiority trial will compare two high-sensitivity C-reactive protein (hs-CRP) target-guided colchicine strategies in 1,768 adults with very-high-risk coronary artery disease after percutaneous coronary intervention, LDL cholesterol ≤1.4 mmol/L, and residual inflammation (hs-CRP 2.0-10.0 mg/L). Participants will be assigned 1:1 to a standard target of 1.0 to <2.0 mg/L or an intensive target of <1.0 mg/L. Both groups will start colchicine 0.25 mg orally once daily, with dose adjustments guided by hs-CRP and tolerability. The primary outcome is the 18-month composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven revascularization. The noninferiority hypothesis compares the standard target strategy with the intensive target strategy, with a prespecified hazard-ratio margin of 1.30.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Adults with coronary artery disease after PCI who meet very-high-risk atherosclerotic cardiovascular disease criteria, have fasting LDL cholesterol ≤1.4 mmol/L within 1 month, and have fasting hs-CRP 2.0-10.0 mg/L within 7 days before enrollment will be randomized through a central system. Randomization is stratified by center, baseline hs-CRP (<5 vs ≥5 mg/L), and age (<65 vs ≥65 years). All participants continue standard coronary disease care and start colchicine 0.25 mg orally daily. At 1 month, the intensive group maintains the dose when hs-CRP is <1.0 mg/L or, if tolerated, increases to 0.5 mg daily otherwise. The standard group reduces to 0.25 mg every other day if hs-CRP is <1.0 mg/L, continues 0.25 mg daily if hs-CRP is 1.0 to <2.0 mg/L, or, if tolerated, increases to 0.5 mg daily if hs-CRP is ≥2.0 mg/L. Participants who increase to 0.5 mg daily undergo repeat assessment after another month. If the assigned target remains unmet after one month at 0.5 mg daily, protocol-directed colchicine is stopped while clinical and safety follow-up continues under the original randomized assignment. Doses may be reduced or treatment stopped for adverse reactions; interruptions may occur during acute infection or elective surgery. Follow-up assessments occur at 1, 3, 6, 12, and 18 months, with an additional 2-month assessment for participants whose dose was increased at 1 month. An independent blinded clinical events committee adjudicates events.

研究类型

介入性

注册 (估计的)

1768

阶段

  • 不适用

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

学习地点

  • 中国
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • Sir Run Run Shaw Hospital
        • 接触：
        • 首席研究员：
          • Wenbin Zhang, Dr.

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

18年 及以上 (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 ≥18 years.
  2. Diagnosed coronary artery disease and prior percutaneous coronary intervention.
  3. Very-high-risk atherosclerotic cardiovascular disease, defined as at least two major ASCVD events or one major ASCVD event plus at least two high-risk conditions according to the 2023 Chinese lipid management guideline.
  4. Fasting LDL cholesterol ≤1.4 mmol/L measured within 1 month before enrollment.
  5. Fasting hs-CRP 2.0-10.0 mg/L measured within 7 days before enrollment, without a recent infection, surgery, trauma, or other acute inflammatory condition.
  6. Voluntary written informed consent.

Exclusion Criteria:

  1. Contraindication or allergy to colchicine, or colchicine use within the prior 4 weeks.
  2. ALT or AST >3 times the upper limit of normal, or eGFR <30 mL/min/1.73 m².
  3. Acute gout flare, serious infection requiring intravenous antibiotics, major surgery, or major trauma within the preceding 3 months.
  4. Malignancy with expected survival <18 months, autoimmune disease, ongoing immunosuppressive treatment, or chronic active infection such as active tuberculosis or hepatitis.
  5. Critical illness, psychiatric illness or cognitive impairment affecting informed participation, or pregnancy, as specified among excluded vulnerable groups in the protocol.
  6. Strong CYP3A4/P-glycoprotein inhibitor (e.g., clarithromycin, itraconazole, cyclosporine, verapamil) or moderate inhibitor (e.g., erythromycin, fluconazole) within 1 month before enrollment.
  7. Concurrent participation in another interventional clinical study.
  8. Any other reason the investigator considers the participant unsuitable.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Standard hs-CRP Target (1.0 to <2.0 mg/L)

Colchicine 0.25 mg orally once daily at initiation, with hs-CRP-guided adjustments to target 1.0 to <2.0 mg/L. At 1 month, reduce to 0.25 mg every other day if hs-CRP <1.0 mg/L; maintain 0.25 mg daily if 1.0 to <2.0 mg/L; or, if tolerated, increase to 0.5 mg daily if ≥2.0 mg/L. If the target remains unmet after one month at 0.5 mg daily, stop protocol-directed colchicine and continue endpoint/safety follow-up. Dose reduction or discontinuation is permitted for adverse reactions.
药品：Colchicine (Colcrys®)

Oral colchicine 0.25 mg daily initially, titrated or reduced according to hs-CRP target 1.0 to <2.0 mg/L and tolerability, with a maximum of 0.5 mg daily

药品：Colchicine (Colcrys®)

Oral colchicine 0.25 mg daily initially, titrated according to hs-CRP target <1.0 mg/L and tolerability, with a maximum of 0.5 mg daily
有源比较器：Intensive hs-CRP Target (<1.0 mg/L)

Colchicine 0.25 mg orally once daily at initiation, with hs-CRP-guided adjustments to target <1.0 mg/L. At 1 month, maintain 0.25 mg daily if hs-CRP <1.0 mg/L; otherwise, if tolerated, increase to 0.5 mg daily. If the target remains unmet after one month at 0.5 mg daily, stop protocol-directed colchicine and continue endpoint/safety follow-up. Dose reduction or discontinuation is permitted for adverse reactions.
药品：Colchicine (Colcrys®)

Oral colchicine 0.25 mg daily initially, titrated or reduced according to hs-CRP target 1.0 to <2.0 mg/L and tolerability, with a maximum of 0.5 mg daily

药品：Colchicine (Colcrys®)

Oral colchicine 0.25 mg daily initially, titrated according to hs-CRP target <1.0 mg/L and tolerability, with a maximum of 0.5 mg daily

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
Major Adverse Cardiovascular Events Through 18 Months
大体时间：From randomization through 18 months

Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, or ischemia-driven coronary revascularization. The primary noninferiority comparison is the hazard ratio for the standard hs-CRP target strategy versus the intensive hs-CRP target strategy, with a prespecified margin of 1.30; events are adjudicated by an independent blinded clinical events committee.
From randomization through 18 months

次要结果测量

结果测量
措施说明
大体时间
Key Safety Composite Event Through 18 Months
大体时间：From randomization through 18 months

Time to first occurrence of CTCAE grade ≥3 gastrointestinal adverse reaction, symptomatic creatine kinase elevation or rhabdomyolysis, ≥30% decline in estimated glomerular filtration rate, or drug-related serious adverse event. A superiority comparison of the two randomized strategies is prespecified; the direction and multiplicity sequence must match the final protocol
From randomization through 18 months
Cardiovascular Death Through 18 Months
大体时间：From randomization through 18 months

Time to cardiovascular death, as adjudicated by the blinded clinical events committee.

Time Frame: From randomization through 18 months
From randomization through 18 months
Nonfatal Myocardial Infarction Through 18 Months
大体时间：From randomization through 18 months

Time to nonfatal myocardial infarction as defined in the protocol and adjudicated by the blinded clinical events committee.
From randomization through 18 months
Nonfatal Ischemic Stroke Through 18 Months
大体时间：From randomization through 18 months

Time to nonfatal ischemic stroke as defined in the protocol and adjudicated by the blinded clinical events committee.
From randomization through 18 months
Ischemia-Driven Revascularization Through 18 Months
大体时间：From randomization through 18 months

Time to PCI or coronary bypass surgery performed because of ischemic symptoms or objective evidence of myocardial ischemia
From randomization through 18 months
Change in hs-CRP From Baseline
大体时间：Baseline and 3, 6, 12, and 18 months

Change in fasting hs-CRP concentration from baseline, expressed in mg/L, at each scheduled follow-up assessment.
Baseline and 3, 6, 12, and 18 months
Proportion With hs-CRP <1.0 mg/L
大体时间：3, 6, 12, and 18 months

Proportion of evaluated participants with fasting hs-CRP <1.0 mg/L at each scheduled assessment.
3, 6, 12, and 18 months
Proportion With hs-CRP <2.0 mg/L
大体时间：3, 6, 12, and 18 months

Proportion of evaluated participants with fasting hs-CRP <2.0 mg/L at each scheduled assessment.
3, 6, 12, and 18 months
Average Daily Colchicine Dose
大体时间：From randomization through 18 months

Average administered daily colchicine dose in milligrams over the treatment period; exact denominator and handling of interruptions to be specified in the statistical analysis plan.
From randomization through 18 months
Colchicine Dose Reduction
大体时间：From randomization through 18 months

Proportion of participants with at least one protocol-directed reduction in colchicine dose.
From randomization through 18 months
Colchicine Discontinuation
大体时间：From randomization through 18 months

Proportion of participants who permanently discontinue protocol-directed colchicine, with reasons recorded
From randomization through 18 months
Cumulative Colchicine Exposure Duration
大体时间：From randomization through 18 months

Total number of days taking colchicine during study follow-up; interruptions and discontinuations are recorded.
From randomization through 18 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

Sir Run Run Shaw Hospital

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 (估计的)

2026年12月1日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2032年12月31日

研究注册日期

首次提交

2026年10月30日

首先提交符合 QC 标准的

2026年10月30日

首次发布 (实际的)

2026年11月5日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年10月30日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TARGET-CHD

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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