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Could a cheap arthritis drug prevent heart attacks?

NCT ID NCT07349875

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,826 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Nanjing First Hospital

    RECRUITING

    Nanjing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.