STunning in Acute Myocardial Infarction - BAS (STAMI-BAS)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    120
  • sponsor
    Vastra Gotaland Region
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Updated on 1 May 2025
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Summary

The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)

Description

Left ventricular (LV) remodeling after ST-elevation myocardial infarction (STEMI) is associated with poor outcomes, but the mechanisms underlying adverse LV remodeling are poorly understood. It is also poorly understood how current guideline-recommended treatments affect early LV remodeling. This low interventional clinical trial will compare the effects of early versus late initiation of the three pharmacotherapies on early LV remodeling and cardiometabolic profiles.

Trial objective:

The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI).

Primary endpoint:

Global longitudinal strain (GLS, %) at day 7±24 hours after PCI, adjusted for baseline (day 0) GLS.

Trial design:

This prospective, 2x2x2 factorial, randomized, controlled, open-label, low intervention clinical trial will enroll subjects with STEMI who undergo primary percutaneous coronary intervention (PCI) within 6 hours of symptom onset.

Trial population:

Patients over the age of 18 with STEMI who undergo primary PCI

Details
Condition Myocardial Infarct
Age 18years or above
Treatment Bisoprolol Oral Tablet, Ramipril Oral Product, Dapagliflozin Oral Product
Clinical Study IdentifierNCT06562582
SponsorVastra Gotaland Region
Last Modified on1 May 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)
Informed consent

Exclusion Criteria

Killip class ≥ 3
Chronic kidney disease with GFR < 25 ml/min/1.73 m2
Pre-existing non-reversible cardiac dysfunction or heart failure
Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor
Absolute or relative contraindication to any one of the study drugs that confers a risk of patient safety if the patient participates in the trial and adheres to the protocol-specified recommendations, per the assessment of the treating physician
Life expectancy less than one year
Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
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