STunning in Acute Myocardial Infarction - Beta Blockers, Angiotensin Converting Enzyme Inhibitors and Sodium/Glucose Cotransporter 2 Inhibitors Trial A Low Intervention Clinical Tria
Overview
- Phase
- Phase 4
- Intervention
- Bisoprolol Oral Tablet
- Conditions
- Myocardial Infarct
- Sponsor
- Vastra Gotaland Region
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Measurement of Global longitudinal strain (GLS, %)
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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)
Detailed 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
Investigators
Eligibility Criteria
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
Arms & Interventions
Bisoprolol
Bisoprolol within 24 hours of PCI
Intervention: Bisoprolol Oral Tablet
Ramipril
Ramipril within 24 hours of PCI
Intervention: Ramipril Oral Product
Dapagliflozin
Dapagliflozin within 24 hours versus
Intervention: Dapagliflozin Oral Product
Outcomes
Primary Outcomes
Measurement of Global longitudinal strain (GLS, %)
Time Frame: day 7±24 hours
GLS adjusted for baseline.
Secondary Outcomes
- Measurement of Left ventricular ejection fraction (LVEF)(day 7±24 hours)
- Concentration of cardiac troponin-T(Day 30)
- Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )(day 7±24 hours)
- Concentration of cardiac troponin-I(Day 30)