Using canagliflozin to reduce vascular inflammation in patients with diabetes and coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CANTOR SING is a pilot, single-center, double-blinded, randomized study that aims to evaluate the effects of canagliflozin, an anti-inflammatory medication, on aortic inflammation in patients with stable coronary artery disease (CAD) and diabetes. The study will enroll 16 patients, who will be randomly assigned to receive either canagliflozin (300 mg daily) or a placebo for a duration of 6 months. The primary endpoint is the change in FDG aortic uptake, measured through imaging, comparing baseline and post-treatment results. Participants will undergo clinical evaluations and blood sample collections throughout the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\) Stable CAD (over 60 days post-myocardial infarction).
* 2\) Diabetes
* 3\) given informed consent.

Exclusion Criteria:

1. severe LV dysfunction (EF\<50%);
2. decompensated heart failure;
3. active infection (e.g. pneumonia, active skin infections, and on antibiotics);
4. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
5. pregnancy (all women of child bearing potential will have a negative BHCG test;
6. breastfeeding;
7. 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.
8. glomerular filtration rate (GFR) \<50 ml/min/1.72m2;
9. Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);
10. Hemoglobin \< 105(women) \<110 (men) g/L; WBC \< 3.0x 10(9)/L, platelet count\< 110x 10(9)/L;
11. 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.
12. unable to give informed consent;

Where it's running

• University of Ottawa Heart Institute
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Kevin Boczar, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Kevin Boczar, MD
• Email: kboczar@ottawaheart.ca
• Phone: 613 696 7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.