Can a gout drug cool down artery inflammation in diabetics?
NCT ID NCT04181996
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
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115 people
The number who actually took part.
- Started
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Aug 2020
- Finished
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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
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18 years and older
- Sex
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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 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: 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
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Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7, Canada
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University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
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