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

STunning in Acute Myocardial Infarction - Beta Blockers, Angiotensin Converting Enzyme Inhibitors and Sodium/Glucose Cotransporter 2 Inhibitors Trial A Low Intervention Clinical Tria

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)

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarct
• Intervention / Treatment: Drug: Bisoprolol Oral Tablet; Drug: Ramipril Oral Product; Drug: Dapagliflozin Oral Product

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Björn Redfors, Professor; Phone Number: +46 31342100; Email: bjoern.redfors@wlab.gu.se
• Study Contact Backup: Name: Margareta Scharin Täng, PhD; Phone Number: 0736916467; Email: margareta.scharin.tang@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Recruiting
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bisoprolol; Bisoprolol within 24 hours of PCI	Drug: Bisoprolol Oral Tablet; Timing of drug intervention after PCI; Other Names: Betablocker
No Intervention: No Bisoprolol; no beta blocker until day 7±12 hours
Active Comparator: Ramipril; Ramipril within 24 hours of PCI	Drug: Ramipril Oral Product; Timing of drug intervention after PCI; Other Names: ACE inhibitor
No Intervention: No Ramipril; no ramipril until day 7±12 hours after PCI
Active Comparator: Dapagliflozin; Dapagliflozin within 24 hours versus	Drug: Dapagliflozin Oral Product; Timing of drug intervention after PCI; Other Names: SGLT2 inhibitor
No Intervention: No Dapagliflozin; no dapagliflozin treatment until day 7±12 hours after PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Global longitudinal strain (GLS, %)	GLS adjusted for baseline.	day 7±24 hours

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Infarct size	MI size assessed by CMRI (sub-study)	Day 30

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: PCI; Dapagliflozin; Bisoprolol; Ramipril; ST infarction; Global longitudinal strain (GLS, %)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Autonomic Agents; Peripheral Nervous System Agents; Protease Inhibitors; Enzyme Inhibitors; Neurotransmitter Agents; Adrenergic Agents; Antihypertensive Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin; Bisoprolol; Ramipril; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: 2024-511789-35-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan has not be decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No