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Recruiting NCT06174753

Dapagliflozin in STEMI

Phase III Interventional ST Elevation Myocardial Infarction Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dapagliflozin 10mg Tab, CMR.
Who it may be relevant to
Registry conditions: ST Elevation Myocardial Infarction, Myocardial Infarction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The University of Ottawa Dapagliflozin in STEMI Randomized Clinical Trial

Overview

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.

Detailed description

DAPA STEMI is a single center, randomized, double-blind, parallel group study in which eligible participants with a STEMI and undergoing PPCI will be recruited and randomly assigned to dapagliflozin or placebo to take for 7 days. Participants will be prescribed study treatment i.e. dapagliflozin (10 mg) or placebo daily for 7 days.

A CMR will be obtained at day 3-5 to assess for infarct size. Participants will have follow-up visits at 30, 90, and 180 days to assess for cardiovascular events.

Interventions

  • Drug Dapagliflozin 10mg Tab
    Dapagliflozin 10 mg daily X 7 days
  • Diagnostic test CMR
    CMR 3-5 days post randomization

Primary outcome measures

  • Infarct Size [Time frame: 3-5 days]
Secondary outcome measures (3)
  • Incidence of Multiple Cardiac Adverse Events (MACE) [Time frame: 3 months, and 6 months]
  • Number of participants with Cardiogenic Shock [Time frame: during initial hospitalization (*up to 30 days)]
  • Number of Participants with Acute Kidney Injury [Time frame: 3 months, and 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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
  • Confirmed ketoacidosis at time of admission
  • Known severe hepatic impairment (Cirrhosis)
  • Severe renal impairment (eGFR < 30 mL/min1.73m2 (based on prior or baseline blood work)
  • Known severe valvular heart disease
  • Need for CABG within 90 days based on the results of the initial coronary angiogram
  • False positive STEMI (based on the results of the coronary angiogram)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University of Ottawa Heart Institute — Ottawa

Identifiers

NCT: NCT06174753 · 20230332-01H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗