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Canagliflozin Targeting Vascular Inflammation

ConditionsDiabetes Type 2Coronary Artery Disease
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

1) Stable CAD (over 60 days post-myocardial infarction).

2) Diabetes

3) given informed consent.

Disqualifiers

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));

Trial design

Design model

Parallel

Treatments tested in this trial

  • Canagliflozin

    Drug

    Canagliflozin tablet 300mg PO daily

  • Placebo

    Drug

    Placebo tablet

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: ActiveActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

Change in inflammatory biomarkers

The investigators will measure inflammatory biomarkers (hsCRP, IL-6, IL-7, IL-8, MCP) at baseline and on study completion (pg/mL)

Time frame
6 months
2

Change in monocyte marker expression

Change in monocyte marker expression (% positive cells) of CD14++CD16-, CD14++CD16+, CD14+CD16+, CD14+CD16-, CD127, and CCR2 from baseline to follow-up

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Source ClinicalTrials.gov
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