Using colchicine to reduce heart problems after heart procedures

Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention

This study is testing if colchicine can help reduce heart problems in Chinese patients with coronary heart disease after they have had heart procedures.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 8862 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (other)
• Locations: 36 sites (Lanzhou, Gansu and 35 other locations)
• Trial ID: NCT06472908 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of colchicine in reducing cardiovascular events in Chinese patients with coronary heart disease (CHD) who have undergone percutaneous coronary intervention (PCI). A total of 8862 participants will be randomly assigned to receive either colchicine at two different doses (0.5 mg/day and 0.375 mg/day) or a placebo, with follow-ups scheduled at various intervals to monitor health outcomes. The study aims to determine the optimal dosage for this population, considering their unique physiological characteristics. The trial is multicenter, double-blind, and event-driven, ensuring rigorous assessment of the treatment's effects.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized patients aged 18 to 80 with coronary heart disease requiring PCI.

Not a fit: Patients with known allergies to colchicine, severe renal or liver dysfunction, or those currently in cardiogenic shock may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for reducing cardiovascular events in Chinese patients with CHD.

How similar studies have performed: While colchicine has been recommended for CHD treatment in other regions, this specific approach in the Chinese population is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Where this trial is running

Lanzhou, Gansu and 35 other locations

• The Second Hospital & Clinical Medical School, Lanzhou University — Lanzhou, Gansu, China (RECRUITING)
• Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (RECRUITING)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China (RECRUITING)
• The First Affiliated Hospital of Dalian Medical University — Dalian, China (RECRUITING)
• The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture — Enshi, China (RECRUITING)
• The First Affiliated Hospital of Harbin Medical University — Harbin, China (RECRUITING)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (RECRUITING)
• Huangshi Central Hospital — Huangshi, China (RECRUITING)
• Shandong Provincial Hospital — Jinan, China (RECRUITING)
• Jingzhou Central Hospital — Jingzhou, China (RECRUITING)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)
• Shanghai Sixth People's Hospital — Shanghai, China (RECRUITING)
• Songjiang Hospital Affiliated with Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)
• The General Hospital of Northern Theater Command of the Chinese People's Liberation Army — Shenyang, China (RECRUITING)
• Dongfeng General Hospital, Hubei University of Medicine — Shiyan, China (RECRUITING)
• Shiyan Renmin Hospital — Shiyan, China (RECRUITING)
• Taihe hospital — Shiyan, China (RECRUITING)
• Suizhou Central Hospital — Suizhou, China (RECRUITING)
• Shanxi Cardiovascular Disease Hospital — Taiyuan, China (RECRUITING)
• China Resources and WISCO General Hospital — Wuhan, China (RECRUITING)
• Fifth Hospital in Wuhan — Wuhan, China (RECRUITING)
• Wuhan Asia Heart Hospital — Wuhan, China (RECRUITING)
• Wuhan Central Hospital — Wuhan, China (RECRUITING)
• Wuhan First Hospital — Wuhan, China (RECRUITING)
• Wuhan Fourth Hospital — Wuhan, China (RECRUITING)
• Wuhan Puren Hospital — Wuhan, China (RECRUITING)
• Wuhan Sixth Hospital, Affiliated Hospital of Jianghan University — Wuhan, China (RECRUITING)
• Wuhan Third Hospital — Wuhan, China (RECRUITING)
• Wuhan Wuchang Hospital — Wuhan, China (RECRUITING)
• The First Affiliated Hospital of Xiamen University — Xiamen, China (RECRUITING)
• Xiangyang Central Hospital — Xiangyang, China (RECRUITING)
• Xiangyang First People's Hospital — Xiangyang, China (RECRUITING)
• Xianning Central Hospital — Xianning, China (RECRUITING)
• Yichang Central People's Hospital — Yichang, China (RECRUITING)
• Fuwai Huazhong Cardiovascular Hospital — Zhengzhou, China (RECRUITING)

Study contacts

• Principal investigator: Xiang Cheng, MD — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Miao Yu, MD

Conditions: Coronary Heart Disease, Percutaneous Coronary Intervention, Colchicine