Actively Recruiting
Efficacy and Safety of Colchicine After PCI
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-03-30
8862
Participants Needed
36
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Colchicine After PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent
- Age 18 to 80 years, any sex
- Hospitalized patients with coronary heart disease requiring PCI
- Completion of all planned PCI during hospitalization
- Receiving standardized coronary artery disease treatment per national guidelines
You will not qualify if you...
- Known allergy to colchicine
- Colchicine taken within 10 days before randomization
- Currently in cardiogenic shock or hemodynamically unstable
- Known inflammatory bowel disease or chronic diarrhea
- Abnormal liver function (ALT greater than 3 times upper limit)
- Abnormal kidney function (eGFR less than 30 mL/min/1.73m2)
- Active cancer reported in medical history
- Receiving or planned treatment with other anti-inflammatory or immunosuppressive drugs
- Pregnant or breastfeeding women or women of childbearing age not using effective contraception
- Any other condition judged by the investigator as unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 36 locations
1
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
2
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
3
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Actively Recruiting
4
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
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5
The First Affiliated Hospital of Dalian Medical University
Dalian, China
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6
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, China
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7
The First Affiliated Hospital of Harbin Medical University
Harbin, China
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8
The First Affiliated Hospital of Anhui Medical University
Hefei, China
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9
Huangshi Central Hospital
Huangshi, China
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10
Shandong Provincial Hospital
Jinan, China
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11
Jingzhou Central Hospital
Jingzhou, China
Actively Recruiting
12
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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13
Shanghai Sixth People's Hospital
Shanghai, China
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14
Songjiang Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai, China
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15
The General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, China
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16
Dongfeng General Hospital, Hubei University of Medicine
Shiyan, China
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17
Shiyan Renmin Hospital
Shiyan, China
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18
Taihe hospital
Shiyan, China
Actively Recruiting
19
Suizhou Central Hospital
Suizhou, China
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20
Shanxi Cardiovascular Disease Hospital
Taiyuan, China
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21
China Resources and WISCO General Hospital
Wuhan, China
Actively Recruiting
22
Fifth Hospital in Wuhan
Wuhan, China
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23
Wuhan Asia Heart Hospital
Wuhan, China
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24
Wuhan Central Hospital
Wuhan, China
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25
Wuhan First Hospital
Wuhan, China
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26
Wuhan Fourth Hospital
Wuhan, China
Actively Recruiting
27
Wuhan Puren Hospital
Wuhan, China
Actively Recruiting
28
Wuhan Sixth Hospital, Affiliated Hospital of Jianghan University
Wuhan, China
Actively Recruiting
29
Wuhan Third Hospital
Wuhan, China
Actively Recruiting
30
Wuhan Wuchang Hospital
Wuhan, China
Actively Recruiting
31
The First Affiliated Hospital of Xiamen University
Xiamen, China
Actively Recruiting
32
Xiangyang Central Hospital
Xiangyang, China
Actively Recruiting
33
Xiangyang First People's Hospital
Xiangyang, China
Actively Recruiting
34
Xianning Central Hospital
Xianning, China
Actively Recruiting
35
Yichang Central People's Hospital
Yichang, China
Actively Recruiting
36
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, China
Actively Recruiting
Research Team
M
Miao Yu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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