STunning in Acute Myocardial Infarction - BAS

Phase 4

Recruiting

• Conditions: Myocardial Infarct
• Interventions: Drug: Dapagliflozin Oral Product; Drug: Ramipril Oral Product; Drug: Bisoprolol Oral Tablet

• Registration Number: NCT06562582
• Lead Sponsor: Vastra Gotaland Region

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

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-20
• Study Start: 2025-01-06
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

1. Killip class ≥ 3
2. Chronic kidney disease with GFR < 25 ml/min/1.73 m2
3. Pre-existing non-reversible cardiac dysfunction or heart failure
4. Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor
5. 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
6. Life expectancy less than one year
7. Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Dapagliflozin Oral Product	Dapagliflozin within 24 hours versus
Ramipril	Ramipril Oral Product	Ramipril within 24 hours of PCI
Bisoprolol	Bisoprolol Oral Tablet	Bisoprolol within 24 hours of PCI

Primary Outcome Measures

Name	Time	Method
Measurement of Global longitudinal strain (GLS, %)	day 7±24 hours	GLS adjusted for baseline.

Secondary Outcome Measures

Name	Time	Method
Concentration of cardiac troponin-T	Day 30	Area under the curve
Measurement of Left ventricular ejection fraction (LVEF)	day 7±24 hours	LVEF adjusted for baseline
Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )	day 7±24 hours	NT-proBNP adjusted for baseline
Concentration of cardiac troponin-I	Day 30	Area under the curve

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden