NCT05427084

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
7mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

June 1, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
2.4 years until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

June 1, 2022

Last Update Submit

April 30, 2026

Conditions

Diabetes Type 2Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • TBR (Tissue-to-blood ratio) of the most-diseased segment (MDS) of the ascending aorta

    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 Outcomes (2)

  • Change in inflammatory biomarkers

    6 months

  • Change in monocyte marker expression

    6 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Canagliflozin 300mg PO daily

Drug: Canagliflozin

Placebo

PLACEBO COMPARATOR

Placebo PO daily

Drug: Placebo

Interventions

CanagliflozinDRUG

Canagliflozin tablet 300mg PO daily

Also known as: Invokana
Active
PlaceboDRUG

Placebo tablet

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Stable CAD (over 60 days post-myocardial infarction).
  • \) Diabetes
  • \) given informed consent.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery Disease

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Kevin Boczar, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Boczar, MD

CONTACT

613 696 7000kboczar@ottawaheart.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 22, 2022

Study Start

November 15, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

CA(1)