Recruiting PHASE3 ST Elevation Myocardial Infarction

New treatment option for ST Elevation Myocardial Infarction

Official title Dapagliflozin in STEMI

ClinicalTrials.gov ID: NCT06174753

What this study is testing

What is Dapagliflozin 10mg Tab?

Dapagliflozin 10mg Tab is an investigational medicine, given as an once-daily, being studied as a potential treatment for st elevation myocardial infarction.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join 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...

You likely can't join 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
See the full eligibility criteria
Who can join
  • 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...
What rules you out
  • 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)

The study team makes the final eligibility decision.

Where it's taking place

  • Ottawa, Ontario, Canada

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.