Efficacy and Safety of Colchicine After PCI

Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Heart Disease; Percutaneous Coronary Intervention; Colchicine
• Intervention / Treatment: Drug: Placebo; Drug: Colchicine 0.5 mg; Drug: Colchicine 0.375 mg

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 8862
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Miao Yu, MD; Phone Number: +8602785726494; Email: yumiaodavid@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Ke-Fei Dou
  • Chongqing, China
    • Recruiting
    • The Second Affiliated Hospital of Chongqing Medical University
    • Contact: Zhi-Yu Ling
  • Dalian, China
    • Recruiting
    • The First Affiliated Hospital of Dalian Medical University
    • Contact: Bo Zhang
  • Enshi, China
    • Recruiting
    • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
    • Contact: Yu-Hua Lei
  • Harbin, China
    • Recruiting
    • The First Affiliated Hospital of Harbin Medical University
    • Contact: De-Chun Yin
  • Hefei, China
    • Recruiting
    • The First Affiliated Hospital of Anhui Medical University
    • Contact: Jun Xie
  • Huangshi, China
    • Recruiting
    • Huangshi Central Hospital
    • Contact: Dao-Qun Jin
  • Jinan, China
    • Recruiting
    • Shandong Provincial Hospital
    • Contact: Hai-Tao Yuan
  • Jingzhou, China
    • Recruiting
    • Jingzhou Central Hospital
    • Contact: Ke-Ping Yang
  • Shanghai, China
    • Recruiting
    • Shanghai sixth people's hospital
    • Contact: Cheng-Xing Shen
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    • Contact: Rui-Yan Zhang
  • Shanghai, China
    • Recruiting
    • Songjiang Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
    • Contact: Lei Hou
  • Shenyang, China
    • Recruiting
    • The General Hospital of Northern Theater Command of the Chinese People's Liberation Army
    • Contact: Geng Wang
  • Shiyan, China
    • Recruiting
    • Taihe Hospital
    • Contact: Zheng Cao
  • Shiyan, China
    • Recruiting
    • Dongfeng General Hospital, Hubei University of Medicine
    • Contact: Xin-Wen Min
  • Shiyan, China
    • Recruiting
    • Shiyan Renmin Hospital
    • Contact: You-En Zhang
  • Suizhou, China
    • Recruiting
    • Suizhou Central Hospital
    • Contact: Wei Yao
  • Taiyuan, China
    • Recruiting
    • Shanxi Cardiovascular Disease Hospital
    • Contact: Xue-Bin Han
  • Wuhan, China
    • Recruiting
    • Wuhan Third Hospital
    • Contact: Dong-Sheng Li
  • Wuhan, China
    • Recruiting
    • Wuhan Puren Hospital
    • Contact: Mei-Chun Zhang
  • Wuhan, China
    • Recruiting
    • China Resources and WISCO General Hospital
    • Contact: Xue-Xiang Lv
  • Wuhan, China
    • Recruiting
    • Fifth Hospital in Wuhan
    • Contact: Li-Feng Hong
  • Wuhan, China
    • Recruiting
    • Wuhan Asia Heart Hospital
    • Contact: Hua Yan
  • Wuhan, China
    • Recruiting
    • Wuhan Central Hospital
    • Contact: Man-Hua Chen
  • Wuhan, China
    • Recruiting
    • Wuhan First Hospital
    • Contact: Li-Qun He
  • Wuhan, China
    • Recruiting
    • Wuhan Fourth Hospital
    • Contact: Li-Qun Hu
  • Wuhan, China
    • Recruiting
    • Wuhan Sixth Hospital, Affiliated Hospital of Jianghan University
    • Contact: Bo Liu
  • Wuhan, China
    • Recruiting
    • Wuhan Wuchang Hospital
    • Contact: Li-Yue Wang
  • Xiamen, China
    • Recruiting
    • The First Affiliated Hospital of Xiamen University
    • Contact: Qiang Xie
  • Xiangyang, China
    • Recruiting
    • Xiangyang Central Hospital
    • Contact: Xiao-Lin Wu
  • Xiangyang, China
    • Recruiting
    • Xiangyang First People's Hospital
    • Contact: Xiao-Lan Li
  • Xianning, China
    • Recruiting
    • Xianning Central Hospital
    • Contact: Shou-Yi Gan
  • Yichang, China
    • Recruiting
    • Yichang Central People's Hospital
    • Contact: Jian Yang
  • Zhengzhou, China
    • Recruiting
    • Fuwai Huazhong Cardiovascular Hospital
    • Contact: Mu-Wei Li
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • The Second Hospital & Clinical Medical School, Lanzhou University
      • Contact: Peng Chang
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Xiang Cheng, Doctor; Phone Number: +8602785726011; Email: nathancx@hust.edu.cn
      • Principal Investigator: Xiang Cheng, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 national guidelines.

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 immunosuppressive drugs;
• (9) Pregnant women, lactating women or women of childbearing age who did not use effective contraceptives;
• (10) Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo, one pill a day, oral intake	Drug: Placebo; Placebo, one pill a day, oral intake; Other Names: no other name
Experimental: Colchicine 0.5 mg; Colchicine 0.5 mg, one pill a day, oral intake	Drug: Colchicine 0.5 mg; Colchicine 0.5 mg, one pill a day, oral intake; Other Names: no other name
Experimental: Colchicine 0.375 mg; Colchicine 0.375 mg, one pill a day, oral intake	Drug: Colchicine 0.375 mg; Colchicine 0.375 mg, one pill a day, oral intake; Other Names: no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization	From randomization to the first occurrence	An estimated 2-4 years period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke	From randomization to the first occurrence	An estimated 2-4 years period
Ischemia-driven revascularization	The number of participants with Ischemia-driven revascularization	An estimated 2-4 years period
Nonfatal myocardial infarction	The number of participants with myocardial infarction	An estimated 2-4 years period
Nonfatal stroke	The number of participants with stroke	An estimated 2-4 years period
Urgent hospitalization for unstable angina	The number of participants with urgent hospitalization for unstable angina	An estimated 2-4 years period
In-stent restenosis	The number of participants with in-stent restenosis	An estimated 2-4 years period
Stent thrombosis	The number of participants with stent thrombosis	An estimated 2-4 years period
Cardiovascular death	The number of participants with cardiovascular death	An estimated 2-4 years period
All-cause mortality	The number of participants with all-cause death	An estimated 2-4 years period

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Xiang Cheng, MD, Wuhan Union Hospital, China

Publications and helpful links

General Publications

• Lawler PR, Bhatt DL, Godoy LC, Luscher TF, Bonow RO, Verma S, Ridker PM. Targeting cardiovascular inflammation: next steps in clinical translation. Eur Heart J. 2021 Jan 1;42(1):113-131. doi: 10.1093/eurheartj/ehaa099.
• Nelson K, Fuster V, Ridker PM. Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055.
• Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115. Erratum In: Eur Heart J. 2021 Aug 31;42(33):3202. doi: 10.1093/eurheartj/ehab265.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Gout Suppressants; Antirheumatic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Colchicine
• Other Study ID Numbers: COLPCI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No