Could a cheap arthritis drug prevent heart attacks?
NCT ID NCT07349875
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding low-dose colchicine (0.5 mg daily) to standard heart treatments can lower the risk of major heart problems like heart attacks and strokes. About 3,800 adults with stable coronary artery disease and non-flow-limiting plaque will be randomly assigned to get colchicine plus standard care or standard care alone. The goal is to see if colchicine's anti-inflammatory effects help protect the heart over up to 3 years.
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 provide a simple, low-cost way to lower the risk of heart attacks and strokes in people with stable coronary artery disease.
- What could go wrong
- This is a large phase 4 trial, but colchicine may cause side effects like stomach upset or liver issues. The benefit may be small or not apply to all patients.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 3,826 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jun 2030
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 years and older
- 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. The subject (or legal guardian) understands the trial requirements and treatment procedure, and signs the written informed consent before undergoing any protocol-specified examinations or procedures; 2. Aged ≥18 years; 3. Clinically diagnosed with chronic coronary syndrome (CCS); 4. CCTA confirms ≥50% stenosis in at least one epicardial coronary artery, and CT fractional flow reserve (CT-FFR) \>0.80. Exclusion Criteria 1. Unable or unwilling to provide informed consent; 2. Unable to complete scheduled follow-up; 3. Underwent PCI within the past 3 months; 4. History of coronary artery bypass grafting (CABG); 5. Diagnosis of acute coronary syndromes (ACS); 6. No coronary plaque or plaque stenosis \<50% (confirmed by CCTA); 7. Lesion-specific CT-FFR ≤0.80 in at least one major epicardial coronary artery; 8. Inflammatory bowel disease (Crohn's disease/ulcerative colitis) or chronic diarrhea; 9. History of gastric ulcer or gastric bleeding; 10. Pregnant/lactating women or women of childbearing age without effective contraception; 11. Neuromuscular disease or non-transient creatine kinase (CK) \>3×upper limit of normal (ULN) (confirmed by ≥2 lab tests); 12. Clinically significant non-transient hematological abnormalities (hemoglobin \<100 g/L, hematocrit \<30%/ \>52%, white blood cell count \<3×10⁹/L, platelet count \<100×10⁹/L; confirmed by ≥2 lab tests); 13. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² (CKD-EPI formula); 14. Liver dysfunction (alanine aminotransferase \>3×ULN and/or total bilirubin \>2×ULN); 15. Current/planned immunosuppressive therapy; 16. Long-term colchicine use for other indications; 17. Definite/suspected colchicine allergy; 18. Active malignant tumor (expected survival \<1 year); 19. Use of potent CYP3A4/P-glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin, clarithromycin) without alternative drugs.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanjing First Hospital
RECRUITINGNanjing, China
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