Status:
RECRUITING
Canagliflozin Targeting Vascular Inflammation
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Conditions:
Diabetes Type 2
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
CANTOR SING is a pilot single center double blinded randomized study. The investigators will compare the effect of canagliflozin (300 mg daily - intervention arm) vs. placebo (control group) on the FD...
Detailed Description
CANTOR SING is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using canagliflozin, on aortic inflammation using imaging, i.e. ascen...
Eligibility Criteria
Inclusion
- 1\) Stable CAD (over 60 days post-myocardial infarction).
- 2\) Diabetes
- 3\) given informed consent.
Exclusion
- severe LV dysfunction (EF\<50%);
- decompensated heart failure;
- active infection (e.g. pneumonia, active skin infections, and on antibiotics);
- active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
- pregnancy (all women of child bearing potential will have a negative BHCG test;
- breastfeeding;
- 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.
- glomerular filtration rate (GFR) \<50 ml/min/1.72m2;
- Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);
- Hemoglobin \< 105(women) \<110 (men) g/L; WBC \< 3.0x 10(9)/L, platelet count\< 110x 10(9)/L;
- 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.
- unable to give informed consent;
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05427084
Start Date
November 15 2024
End Date
December 1 2026
Last Update
December 11 2024
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7