Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention

Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• (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.

Locations
Other Locations
China
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Beijing
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
RECRUITING
Enshi
The First Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huangshi Central Hospital
RECRUITING
Huangshi
Shandong Provincial Hospital
RECRUITING
Jinan
Jingzhou Central Hospital
RECRUITING
Jingzhou
The Second Hospital & Clinical Medical School, Lanzhou University
RECRUITING
Lanzhou
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shanghai Sixth People's Hospital
RECRUITING
Shanghai
Songjiang Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
The General Hospital of Northern Theater Command of the Chinese People's Liberation Army
RECRUITING
Shenyang
Dongfeng General Hospital, Hubei University of Medicine
RECRUITING
Shiyan
Shiyan Renmin Hospital
RECRUITING
Shiyan
Taihe hospital
RECRUITING
Shiyan
Suizhou Central Hospital
RECRUITING
Suizhou
Shanxi Cardiovascular Disease Hospital
RECRUITING
Taiyuan
China Resources and WISCO General Hospital
RECRUITING
Wuhan
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Fifth Hospital in Wuhan
RECRUITING
Wuhan
Wuhan Asia Heart Hospital
RECRUITING
Wuhan
Wuhan Central Hospital
RECRUITING
Wuhan
Wuhan First Hospital
RECRUITING
Wuhan
Wuhan Fourth Hospital
RECRUITING
Wuhan
Wuhan Puren Hospital
RECRUITING
Wuhan
Wuhan Sixth Hospital, Affiliated Hospital of Jianghan University
RECRUITING
Wuhan
Wuhan Third Hospital
RECRUITING
Wuhan
Wuhan Wuchang Hospital
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Xiangyang Central Hospital
RECRUITING
Xiangyang
Xiangyang First People's Hospital
RECRUITING
Xiangyang
Xianning Central Hospital
RECRUITING
Xianning
Yichang Central People's Hospital
RECRUITING
Yichang
Fuwai Huazhong Cardiovascular Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Miao Yu, MD
yumiaodavid@126.com
+8602785726494
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 8862
Treatments
Experimental: Colchicine 0.5 mg
Colchicine 0.5 mg, one pill a day, oral intake
Experimental: Colchicine 0.375 mg
Colchicine 0.375 mg, one pill a day, oral intake
Placebo_comparator: Placebo
Placebo, one pill a day, oral intake
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov