Canagliflozin Targeting Vascular Inflammation (CANTORSING)

April 30, 2026 updated by: Ottawa Heart Institute Research Corporation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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. ascending aortic FDG uptake. The current proposal uses a randomized design to evaluate the effect of canagliflozin vs. placebo on aortic inflammation activity over 6 months measured using FDG PET.

At the University of Ottawa Heart Institute (UOHI) patients with diabetes and stable CAD (defined as patients over 60 days post-myocardial infarction) will be recruited.

Patients who meet inclusion/exclusion criteria will undergo clinical evaluation, FDG PET imaging with contrast-CT, and blood sample collection. HbA1C, Fasting Blood Sugar (FBS), lipids, C-reactive protein (CRP), creatinine (CR), glomerular filtration rate (GFR), complete blood count (CBC), hemoglobin, liver function tests - AST, ALT, creatine kinase (CK) will be collected from the patient's clinical data or if not available may be collected as part of the study.

Patients recruited into the CANTOR SING study will be randomized to receive either an oral canagliflozin 300 mg capsule or placebo capsule administered once daily for 6 months. Patients will take the medication for 6 months. The study will be conducted in a double-blinded fashion.

Patients will be followed up every 3 months for the 6-month evaluation period. Clinical evaluation and blood collection for labs (CBC, electrolytes, CPK, ALT, AST, creatinine) will performed at baseline and will be repeated every 3 months for a a total of 6 months of follow-up. FDG PET imaging with contrast-CT will be repeated at 6 months. Finally, blood will be collected at baseline and 6 months.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Canagliflozin 300mg PO daily
Drug: Canagliflozin
Canagliflozin tablet 300mg PO daily
Other Names:
  • Invokana
Placebo Comparator: Placebo
Placebo PO daily
Drug: Placebo
Placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBR (Tissue-to-blood ratio) of the most-diseased segment (MDS) of the ascending aorta
Time Frame: 6 months
TBR (Tissue-to-blood ratio) is a marker of arterial plaque inflammation. It will be measured in the maximum disease segment (MDS)(the segment with the highest FDG uptake at baseline) in the aorta
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inflammatory biomarkers
Time Frame: 6 months
The investigators will measure inflammatory biomarkers (hsCRP, IL-6, IL-7, IL-8, MCP) at baseline and on study completion (pg/mL)
6 months
Change in monocyte marker expression
Time Frame: 6 months
Change in monocyte marker expression (% positive cells) of CD14++CD16-, CD14++CD16+, CD14+CD16+, CD14+CD16-, CD127, and CCR2 from baseline to follow-up
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: Kevin Boczar, MD, Ottawa Heart Institute Research Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220176-01H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe