Efficacy and Safety of Colchicine After PCI

Last updated: March 25, 2025
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting

Phase

3

Condition

Coronary Artery Disease

Myocardial Ischemia

Cardiovascular Disease

Treatment

Colchicine 0.375 mg

Placebo

Colchicine 0.5 mg

Clinical Study ID

NCT06472908
COLPCI
  • Ages 18-80
  • All Genders

Study Summary

Colchicine (0.5 mg/day) was recommended by the U.S. Food and Drug Administration in 2023 for the anti-inflammatory treatment of coronary heart disease (CHD). However, colchicine is still not approved for CHD treatment in China. There is no large-scale clinical evidence that colchicine can be used to treat Chinese patients with CHD. Considering the low body weight of the East Asian population, it is unclear whether the recommended standard dose (0.5 mg/day) is suitable for Chinese patients. Therefore, we need to further explore the effects of different doses of colchicine on the efficacy and safety of clinical endpoints in the Chinese population with CHD.

This study is a multicenter, prospective, randomized, controlled, double-blind, event-driven clinical study conducted in China. The primary objective of this study is to determine whether long-term treatment with different doses of colchicine reduces the incidence of cardiovascular events in Chinese patients undergoing PCI. The secondary objective is to determine the safety of long-term treatment with different doses of colchicine in this patient population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (1) Capable and willing to provide informed consent;

  • (2) Age ≥18 and ≤80 years old, regardless of sex;

  • (3) Hospitalized patients with CHD requiring PCI;

  • (4) Completion of all planned PCI during hospitalization;

  • (5) Standardized treatment of coronary artery disease according to nationalguidelines.

Exclusion

Exclusion Criteria:

  • (1) Known allergy to colchicine;

  • (2) Colchicine taken within 10 days prior to randomization group;

  • (3) Patients currently in cardiogenic shock or hemodynamically unstable;

  • (4) Patients with known inflammatory bowel disease or chronic diarrhea;

  • (5) Abnormal liver function (ALT> 3 times the upper limit of normal);

  • (6) Abnormal renal function (eGFR<30mL/min/1.73m2);

  • (7) Active malignant tumors reported in past medical history;

  • (8) Existing or planned treatment with other anti-inflammatory or immunosuppressivedrugs;

  • (9) Pregnant women, lactating women or women of childbearing age who did not useeffective contraceptives;

  • (10) Any other circumstances in which the investigator judges that the patient isnot suitable to participate in the clinical trial.

Study Design

Total Participants: 8862
Treatment Group(s): 3
Primary Treatment: Colchicine 0.375 mg
Phase: 3
Study Start date:
July 09, 2024
Estimated Completion Date:
August 31, 2028

Study Description

After informed consent, 8862 subjects who meet all inclusion will be randomly assigned to receive colchicine (0.5 mg/day), colchicine (0.375 mg/day), or placebo (1:1:1 allocation ratio), with follow-up at months (1, 6, 12, 18, 24...) after randomization, and phone assessments at months (3, 9, 15, 21...). The occurrence of any endpoints or other adverse events will be assessed every 3 months. Subjects will also receive standard medical care for antiplatelets, control of dyslipidemia, hypertension, angina and diabetes as directed by national guidelines. All suspected cardiovascular endpoints will be adjudicated by the Clinical Event Committee (CEC, consisting of three experienced members blinded as to allocation of therapy). The Data and Safety Monitoring Board (DSMB, consisting of five fully independent members) will review unblinded safety data as detailed in the DSMB charter. An interim analysis is planned after approximately 50% of primary endpoints have been positively adjudicated. The DSMB charter will pre-specify the methodology for the interim analysis and the rules for early termination of the study.

Connect with a study center

  • The Second Hospital & Clinical Medical School, Lanzhou University

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing,
    China

    Active - Recruiting

  • Cangzhou Central Hospital

    Cangzhou,
    China

    Site Not Available

  • The First Affiliated Hospitalof Chongqing Medical University

    Chongqing,
    China

    Site Not Available

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian,
    China

    Active - Recruiting

  • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

    Enshi,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei,
    China

    Active - Recruiting

  • Huangshi Central Hospital

    Huangshi,
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan,
    China

    Active - Recruiting

  • Jingzhou Central Hospital

    Jingzhou,
    China

    Active - Recruiting

  • Nanjing First Hospital

    Nanjing,
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Sixth People's Hospital

    Shanghai,
    China

    Active - Recruiting

  • Songjiang Hospital Affiliated with Shanghai Jiao Tong University School of Medicine

    Shanghai,
    China

    Active - Recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai,
    China

    Site Not Available

  • The General Hospital of Northern Theater Command of the Chinese People's Liberation Army

    Shenyang,
    China

    Active - Recruiting

  • Dongfeng General Hospital, Hubei University of Medicine

    Shiyan,
    China

    Active - Recruiting

  • Shiyan Renmin Hospital

    Shiyan,
    China

    Active - Recruiting

  • Taihe hospital

    Shiyan,
    China

    Active - Recruiting

  • Suizhou Central Hospital

    Suizhou,
    China

    Active - Recruiting

  • Shanxi Cardiovascular Disease Hospital

    Taiyuan,
    China

    Active - Recruiting

  • China Resources and WISCO General Hospital

    Wuhan,
    China

    Active - Recruiting

  • Fifth Hospital in Wuhan

    Wuhan,
    China

    Active - Recruiting

  • Wuhan Asia Heart Hospital

    Wuhan,
    China

    Active - Recruiting

  • Wuhan Central Hospital

    Wuhan,
    China

    Active - Recruiting

  • Wuhan First Hospital

    Wuhan,
    China

    Active - Recruiting

  • Wuhan Fourth Hospital

    Wuhan,
    China

    Active - Recruiting

  • Wuhan Puren Hospital

    Wuhan,
    China

    Active - Recruiting

  • Wuhan Sixth Hospital, Affiliated Hospital of Jianghan University

    Wuhan,
    China

    Active - Recruiting

  • Wuhan Third Hospital

    Wuhan,
    China

    Active - Recruiting

  • Wuhan Wuchang Hospital

    Wuhan,
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan,
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen,
    China

    Active - Recruiting

  • Xiangyang Central Hospital

    Xiangyang,
    China

    Active - Recruiting

  • Xiangyang First People's Hospital

    Xiangyang,
    China

    Active - Recruiting

  • Xianning Central Hospital

    Xianning,
    China

    Active - Recruiting

  • Yanbian University Affiliated Hospital

    Yanbian,
    China

    Site Not Available

  • Yichang Central People's Hospital

    Yichang,
    China

    Active - Recruiting

  • Fuwai Huazhong Cardiovascular Hospital

    Zhengzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Site Not Available

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