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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

1768

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • Sir Run Run Shaw Hospital
        • コンタクト：
        • 主任研究者：
          • Wenbin Zhang, Dr.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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

薬：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
アクティブコンパレータ：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.
薬：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

薬：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Major Adverse Cardiovascular Events Through 18 Months
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Key Safety Composite Event Through 18 Months
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sir Run Run Shaw Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年12月1日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2032年12月31日

試験登録日

最初に提出

2026年10月30日

QC基準を満たした最初の提出物

2026年10月30日

最初の投稿 (実際)

2026年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年10月30日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • TARGET-CHD

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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