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

Canagliflozin Targeting Vascular Inflammation: An Ottawa Imaging Study - A Pilot Study

This study is testing if the medication canagliflozin can help reduce inflammation in the blood vessels of people with diabetes and coronary artery disease.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (other)
• Drugs / interventions: methotrexate, prednisone
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT05427084 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with stable coronary artery disease who are over 60 days post-myocardial infarction and have diabetes.

Not a fit: Patients with severe left ventricular dysfunction, active infections, or other significant inflammatory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic approach to reduce vascular inflammation in patients with diabetes and coronary artery disease.

How similar studies have performed: While this approach is novel in targeting vascular inflammation specifically with canagliflozin, similar studies have shown promise in using anti-inflammatory therapies for cardiovascular conditions.

Eligibility criteria

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 this trial is running

Ottawa, Ontario

• 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

Conditions: Diabetes Type 2, Coronary Artery Disease