STunning in Acute Myocardial Infarction - BAS

NCT ID: NCT06562582

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-06

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarct

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This prospective, 2x2x2 factorial, randomized, controlled,
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bisoprolol

Bisoprolol within 24 hours of PCI

Group Type ACTIVE_COMPARATOR

Bisoprolol Oral Tablet

Intervention Type DRUG

Timing of drug intervention after PCI

No Bisoprolol

no beta blocker until day 7±12 hours

Group Type NO_INTERVENTION

No interventions assigned to this group

Ramipril

Ramipril within 24 hours of PCI

Group Type ACTIVE_COMPARATOR

Ramipril Oral Product

Intervention Type DRUG

Timing of drug intervention after PCI

No Ramipril

no ramipril until day 7±12 hours after PCI

Group Type NO_INTERVENTION

No interventions assigned to this group

Dapagliflozin

Dapagliflozin within 24 hours versus

Group Type ACTIVE_COMPARATOR

Dapagliflozin Oral Product

Intervention Type DRUG

Timing of drug intervention after PCI

No Dapagliflozin

no dapagliflozin treatment until day 7±12 hours after PCI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bisoprolol Oral Tablet

Timing of drug intervention after PCI

Intervention Type DRUG

Ramipril Oral Product

Timing of drug intervention after PCI

Intervention Type DRUG

Dapagliflozin Oral Product

Timing of drug intervention after PCI

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Betablocker ACE inhibitor SGLT2 inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Björn Redfors, Professor

Role: CONTACT

+46 31342100

Margareta Scharin Täng, PhD

Role: CONTACT

0736916467

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-511789-35-00

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.