Efficacy and Safety of Colchicine After PCI
- Conditions
- Percutaneous Coronary InterventionColchicineCoronary Heart Disease
- Interventions
- Registration Number
- NCT06472908
- Lead Sponsor
- Wuhan Union Hospital, China
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 8862
- (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.
- (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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, one pill a day, oral intake Colchicine 0.5 mg Colchicine 0.5 mg Colchicine 0.5 mg, one pill a day, oral intake Colchicine 0.375 mg Colchicine 0.375 mg Colchicine 0.375 mg, one pill a day, oral intake
- Primary Outcome Measures
Name Time Method Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and ischemia-driven revascularization An estimated 2-4 years period From randomization to the first occurrence
- Secondary Outcome Measures
Name Time Method Ischemia-driven revascularization An estimated 2-4 years period The number of participants with Ischemia-driven revascularization
Nonfatal myocardial infarction An estimated 2-4 years period The number of participants with myocardial infarction
Nonfatal stroke An estimated 2-4 years period The number of participants with stroke
In-stent restenosis An estimated 2-4 years period The number of participants with in-stent restenosis
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke An estimated 2-4 years period From randomization to the first occurrence
Urgent hospitalization for unstable angina An estimated 2-4 years period The number of participants with urgent hospitalization for unstable angina
Stent thrombosis An estimated 2-4 years period The number of participants with stent thrombosis
Cardiovascular death An estimated 2-4 years period The number of participants with cardiovascular death
All-cause mortality An estimated 2-4 years period The number of participants with all-cause death
Trial Locations
- 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