Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
8862 participants
INTERVENTIONAL
2024-07-09
2028-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Colchicine 0.5 mg
Colchicine 0.5 mg, one pill a day, oral intake
Colchicine 0.5 mg
Colchicine 0.5 mg, one pill a day, oral intake
Colchicine 0.375 mg
Colchicine 0.375 mg, one pill a day, oral intake
Colchicine 0.375 mg
Colchicine 0.375 mg, one pill a day, oral intake
Placebo
Placebo, one pill a day, oral intake
Placebo
Placebo, one pill a day, oral intake
Interventions
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Colchicine 0.5 mg
Colchicine 0.5 mg, one pill a day, oral intake
Colchicine 0.375 mg
Colchicine 0.375 mg, one pill a day, oral intake
Placebo
Placebo, one pill a day, oral intake
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (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
* (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.
18 Years
80 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Xiang Cheng
Director in the department of cardiology
Principal Investigators
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Xiang Cheng, MD
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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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, 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
Countries
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Central Contacts
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Facility Contacts
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Peng Chang
Role: primary
Ke-Fei Dou
Role: primary
Zhi-Yu Ling
Role: primary
Bo Zhang
Role: primary
Yu-Hua Lei
Role: primary
De-Chun Yin
Role: primary
Jun Xie
Role: primary
Dao-Qun Jin
Role: primary
Hai-Tao Yuan
Role: primary
Ke-Ping Yang
Role: primary
Rui-Yan Zhang
Role: primary
Cheng-Xing Shen
Role: primary
Lei Hou
Role: primary
Geng Wang
Role: primary
Xin-Wen Min
Role: primary
You-En Zhang
Role: primary
Zheng Cao
Role: primary
Wei Yao
Role: primary
Xue-Bin Han
Role: primary
Xue-Xiang Lv
Role: primary
Li-Feng Hong
Role: primary
Hua Yan
Role: primary
Man-Hua Chen
Role: primary
Li-Qun He
Role: primary
Li-Qun Hu
Role: primary
Mei-Chun Zhang
Role: primary
Bo Liu
Role: primary
Dong-Sheng Li
Role: primary
Li-Yue Wang
Role: primary
Qiang Xie
Role: primary
Xiao-Lin Wu
Role: primary
Xiao-Lan Li
Role: primary
Shou-Yi Gan
Role: primary
Jian Yang
Role: primary
Mu-Wei Li
Role: primary
References
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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.
Other Identifiers
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COLPCI
Identifier Type: -
Identifier Source: org_study_id
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