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Can a gout drug cool down artery inflammation in diabetics?

NCT ID NCT04181996

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether colchicine, a drug used for gout, can reduce inflammation in the arteries of people with diabetes who recently had a heart attack or stroke. Researchers used a special PET scan to measure inflammation in the blood vessels. 115 participants were randomly assigned to receive colchicine or a placebo for 6 months. The goal was to see if colchicine could lower inflammation and potentially prevent future cardiovascular events.

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 point toward a new way to prevent heart attacks and strokes in people with diabetes by targeting inflammation.
What could go wrong
This is a small, early-phase study (115 people) focused on imaging markers, not clinical events. Colchicine may not reduce inflammation enough or could cause side effects like stomach upset.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

115 people

The number who actually took part.

Started

Aug 2020

Finished

Dec 2025

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: Patients who have: 1. Type 2 Diabetes (on diet, oral hypo-glycemic agents and/or insulin) or pre-diabetes (defined by Diabetes Canada as HbA1C=6.0-6.45% or increased fasting blood sugar (FBS) (6.1-6.9 mmol/L) or impaired glucose tolerance); 2. suffered a recent cardiovascular event (≤120 days post ACS (i.e. STEMI or nonSTEMI) or TIA/stroke with associated large vessel atherosclerotic disease confirmed on US, CT or MRI; 3. stable symptoms and hemodynamics; 4. age ≥18 years; 5. given informed consent. Standard definitions will be used for STEMI, NSTEMI, and for ischemic stroke confirmed by CT or MRI and TIA confirmed by a neurologist. Exclusion Criteria: Patients who have 1. planned revascularization of infarct or stroke related artery more than 120 days after the qualifying/index event; 2. a recent CV event likely to have been embolic in the opinion of the neurologist or cardiologist; 3. recent CV event likely to have been secondary to myocardial infarction with non-obstructive coronary arteries (MINOCA) in the opinion of the cardiologist; 4. severe LV dysfunction (EF\<30%); 5. severe valve disease requiring intervention; 6. decompensated heart failure; 7. active infection (e.g. pneumonia, active skin infections, and on antibiotics); 8. chronic diarrhea; 9. immune compromise (e.g. recurrent infection); 10. history of cancer within the last 3 years (other than a successfully treated cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix). 11. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate)); 12. pregnancy (all women of child bearing potential will have a negative BHCG test; 13. breastfeeding; 14. Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception. 15. glomerular filtration rate (GFR) \<50 ml/min/1.72m2 16. Use of potent p-glycoprotein inhibitors (i.e. systemic cyclosporine, clarithromycin, or systemic ketoconazole) or a strong CYP3A4 inhibitor (i.e. ritonavir, clarithromycin, or systemic ketoconazole); 17. Hemoglobin \< 105(women) \<110 (men) g/L; WBC \< 3.0x 10(9)/L, platelet count\< 110x 10(9)/L; 18. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease or with alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal. 19. unable to give informed consent; 20. TIA/Stroke patients with atrial fibrillation Exclusion for CTA portion of the protocol: Patients with dye allergy or those with GRF \<60 will not undergo CTA but will have PET/CT.

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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

  • Mazankowski Alberta Heart Institute

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7, Canada

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