NCT06174753

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P50-P75 for phase_3

Timeline
19mo left

Started Jan 2025

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

Study Progress45%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

December 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

December 7, 2023

Last Update Submit

February 18, 2026

Conditions

ST Elevation Myocardial InfarctionMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Infarct Size

    Infarct size (% of total LV mass) measured by CMR

    3-5 days

Secondary Outcomes (3)

  • Incidence of Multiple Cardiac Adverse Events (MACE)

    3 months, and 6 months

  • Number of participants with Cardiogenic Shock

    during initial hospitalization (*up to 30 days)

  • Number of Participants with Acute Kidney Injury

    3 months, and 6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Dapagliflozin 10mg daily X 7 days

Drug: Dapagliflozin 10mg TabDiagnostic Test: CMR

Placebo

PLACEBO COMPARATOR

Placebo daily X 7 days

Diagnostic Test: CMR

Interventions

Dapagliflozin 10mg TabDRUG

Dapagliflozin 10 mg daily X 7 days

Treatment
CMRDIAGNOSTIC_TEST

CMR 3-5 days post randomization

PlaceboTreatment

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years
  • Any contraindication to undergo CMR imaging
  • Killip 4 (Cardiogenic shock on presentation)
  • Therapy with SGLT2i within last 8 weeks
  • Type 1 diabetes mellitus
  • Pregnancy
  • Nursing mother
  • Unwilling to use appropriate forms of contraception, as applicable
  • Chronic symptomatic HF with prior hospitalization for HF within the last year
  • hospitalization
  • Known history of prior MI
  • Any non-CV condition with a life expectancy of less than one year
  • Previous randomization in the present study
  • Participation in a study with another investigational device or drug \< four weeks
  • Inability to provide informed consent
  • +6 more criteria

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

ST Elevation Myocardial InfarctionMyocardial Infarction

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Michel LeMay, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Poppy MacPhee, BScN

CONTACT

6136967000pmacphee@ottawaheart.ca

Tanya Abarbanel

CONTACT

613-696-7000tabarbanel@ottawaheart.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a single center, randomized, double-blind, parallel group study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 18, 2023

Study Start

January 20, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)