Efficacy and Safety of Colchicine After PCI
1 other identifier
interventional
8,862
1 country
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2024
Typical duration for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2024
CompletedFirst Posted
Study publicly available on registry
June 25, 2024
CompletedStudy Start
First participant enrolled
July 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
March 30, 2025
March 1, 2025
3.7 years
June 19, 2024
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
An estimated 2-4 years period
Ischemia-driven revascularization
An estimated 2-4 years period
Nonfatal myocardial infarction
An estimated 2-4 years period
Nonfatal stroke
An estimated 2-4 years period
Urgent hospitalization for unstable angina
An estimated 2-4 years period
- +4 more secondary outcomes
Study Arms (3)
Colchicine 0.5 mg
EXPERIMENTALColchicine 0.5 mg, one pill a day, oral intake
Colchicine 0.375 mg
EXPERIMENTALColchicine 0.375 mg, one pill a day, oral intake
Placebo
PLACEBO COMPARATORPlacebo, one pill a day, oral intake
Interventions
Colchicine 0.5 mg, one pill a day, oral intake
Colchicine 0.375 mg, one pill a day, oral intake
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, China
The First Affiliated Hospital of Harbin Medical University
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Huangshi Central Hospital
Huangshi, China
Shandong Provincial Hospital
Jinan, China
Jingzhou Central Hospital
Jingzhou, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Songjiang Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai, China
The General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, China
Dongfeng General Hospital, Hubei University of Medicine
Shiyan, China
Shiyan Renmin Hospital
Shiyan, China
Taihe hospital
Shiyan, China
Suizhou Central Hospital
Suizhou, China
Shanxi Cardiovascular Disease Hospital
Taiyuan, China
China Resources and WISCO General Hospital
Wuhan, China
Fifth Hospital in Wuhan
Wuhan, China
Wuhan Asia Heart Hospital
Wuhan, China
Wuhan Central Hospital
Wuhan, China
Wuhan First Hospital
Wuhan, China
Wuhan Fourth Hospital
Wuhan, China
Wuhan Puren Hospital
Wuhan, China
Wuhan Sixth Hospital, Affiliated Hospital of Jianghan University
Wuhan, China
Wuhan Third Hospital
Wuhan, China
Wuhan Wuchang Hospital
Wuhan, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Xiangyang Central Hospital
Xiangyang, China
Xiangyang First People's Hospital
Xiangyang, China
Xianning Central Hospital
Xianning, China
Yichang Central People's Hospital
Yichang, China
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, China
Related Publications (3)
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.
PMID: 32176778RESULTNelson 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.
PMID: 37558377RESULTFiolet 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.
PMID: 33769515RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiang Cheng, MD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director in the department of cardiology
Study Record Dates
First Submitted
June 19, 2024
First Posted
June 25, 2024
Study Start
July 9, 2024
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
March 30, 2025
Record last verified: 2025-03