Can a common gout pill shield hearts after stents?
NCT ID NCT06472908
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests whether taking a daily low dose of colchicine, an anti-inflammatory drug, can reduce the risk of heart attacks, strokes, and other heart problems in Chinese patients who have had a stent placed for coronary heart disease. Researchers will compare two different doses of colchicine against a placebo in about 8,800 patients. The goal is to find out if this treatment is both effective and safe for this population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- colchicine
- What this could lead to
- If it works, this could establish colchicine as a standard anti-inflammatory treatment to prevent future heart attacks and strokes in Chinese patients after stent placement.
- What could go wrong
- The trial is large but still experimental in China. Colchicine may cause side effects, and the lower dose might not work as well, or the higher dose might be less safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 8,862 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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China Resources and WISCO General Hospital
Wuhan, Hubei, China
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Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
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Dongfeng General Hospital, Hubei University of Medicine
Shiyan, Hubei, China
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Fifth Hospital in Wuhan
Wuhan, Hubei, China
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Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
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Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan, China
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Huangshi Central Hospital
Huangshi, Hubei, China
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Jingzhou Central Hospital
Jingzhou, Hubei, China
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
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Shandong Provincial Hospital
Jinan, Shandong, China
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Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
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Shanxi Cardiovascular Disease Hospital
Taiyuan, Shanxi, China
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Shiyan Renmin Hospital
Shiyan, Hubei, China
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Songjiang Hospital Affiliated with Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
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Suizhou Central Hospital
Suizhou, Hubei, China
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Taihe hospital
Shiyan, Hubei, China
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The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, Hubei, China
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
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The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
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The First Affiliated Hospital of Harbin Medical University
Harbin, Harbin, China
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
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The General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, Liaoning, China
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
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Wuhan Asia Heart Hospital
Wuhan, Hubei, China
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Wuhan Central Hospital
Wuhan, Hubei, China
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Wuhan First Hospital
Wuhan, Hubei, China
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Wuhan Fourth Hospital
Wuhan, Hubei, China
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Wuhan Puren Hospital
Wuhan, Hubei, China
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Wuhan Sixth Hospital, Affiliated Hospital of Jianghan University
Wuhan, Hubei, China
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Wuhan Third Hospital
Wuhan, Hubei, China
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Wuhan Wuchang Hospital
Wuhan, Hubei, China
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Xiangyang Central Hospital
Xiangyang, Hubei, China
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Xiangyang First People's Hospital
Xiangyang, Hubei, China
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Xianning Central Hospital
Xianning, Hubei, China
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Yichang Central People's Hospital
Yichang, Hubei, China
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Other studies related to the condition(s) this trial covers.
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