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Efficacy and Safety of Colchicine After PCI
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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.
Official title: Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
8862
Start Date
2024-07-09
Completion Date
2028-08-31
Last Updated
2025-03-30
Healthy Volunteers
No
Interventions
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
Locations (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, 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