The University of Ottawa Dapagliflozin in STEMI Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The goal of this clinical trial is to assess the safety and efficacy of SGLT2i in limiting infarct size in patients with STEMI referred for PPCI. Eligible STEMI patients enrolled into the trial will be randomized to a SGLT2i or placebo. Cardiovascular Magnetic Resonance (CMR) imaging will be used to determine the infarct size.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patients referred for PPCI meeting the following criteria are eligible for the study:

• Ischemic chest discomfort of ≥30 minutes duration, and

• Onset of chest pain ≤12 hours prior to entry into the study, and

• One of the following High-Risk criteria on a standard 12 lead ECG:

• a. Anterior STEMI with ST-segment elevation ≥2mm (0.2 mV) in each of at least 2 contiguous precordial leads (V1-V6) b. Extensive non-anterior STEMI defined as ST-segment elevation of \>1mm in two or more contiguous non-anterior leads accompanied by i. 8 or more leads with \> 1 mm ST elevation or depression, or both; OR ii. Sum of ST- segment elevation \>20mm

Locations
Other Locations
Canada
University of Ottawa Heart Institute
RECRUITING
Ottawa
Contact Information
Primary
Poppy MacPhee, BScN
pmacphee@ottawaheart.ca
6136967000
Backup
Tanya Abarbanel
tabarbanel@ottawaheart.ca
613-696-7000
Time Frame
Start Date: 2025-01-20
Estimated Completion Date: 2026-09
Participants
Target number of participants: 256
Treatments
Experimental: Treatment
Dapagliflozin 10mg daily X 7 days
Placebo_comparator: Placebo
Placebo daily X 7 days
Related Therapeutic Areas
Sponsors
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov