NCT05427084 Canagliflozin Targeting Vascular Inflammation
| NCT ID | NCT05427084 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Diabetes Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-11-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2024-11-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 FDG aortic uptake in patients with stable CAD (over 60 days post-myocardial infarction) after a 6-month period of treatment. The investigators plan to enroll 8 patients in each arm (total sample size: 16 patients). Primary endpoint is the change in FDG aortic uptake between baseline and 6 months in each arm.
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;
Contact & Investigator
Kevin Boczar, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT05427084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05427084 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05427084 currently recruiting?
Yes, NCT05427084 is actively recruiting participants. Contact the research team at kboczar@ottawaheart.ca for enrollment information.
Where is the NCT05427084 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT05427084 clinical trial?
NCT05427084 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Kevin Boczar, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 24 participants.
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