Efficacy and Safety of Colchicine After PCI
NCT Number: NCT06472908
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Coronary Heart Disease|Percutaneous Coronary Intervention|Colchicine
Interventions: DRUG: Colchicine 0.5 mg|DRUG: Colchicine 0.375 mg|DRUG: Placebo
Sponsor: Wuhan Union Hospital, China
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 8862
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-06
Completion Date: 2028-08-31
Locations: 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|Cangzhou Central Hospital, Cangzhou, China|The First Affiliated Hospitalof Chongqing Medical University, Chongqing, 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|Nanjing First Hospital, Nanjing, 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|Xinhua Hospital Affiliated to 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|Zhongnan Hospital of Wuhan University, 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|Yanbian University Affiliated Hospital, Yanbian, China|Yichang Central People's Hospital, Yichang, China|Fuwai Huazhong Cardiovascular Hospital, Zhengzhou, China|The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

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.

Primary Outcome Measures: 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: 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