| Trial ID: | L5027 |
| Source ID: | NCT05427084
|
| Associated Drug: |
Canagliflozin
|
| Title: |
Canagliflozin Targeting Vascular Inflammation
|
| Acronym: |
CANTORSING
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 2|Coronary Artery Disease
|
| Interventions: |
DRUG: Canagliflozin|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: 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), 6 months|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, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Ottawa Heart Institute Research Corporation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-11-15
|
| Completion Date: |
2026-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-11
|
| Locations: |
University of Ottawa Heart Institute, Ottawa, Ontario, K1Y 4W7, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT05427084
|
