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

Vastra Gotaland Region

Status and phase: Enrolling; Phase 4

Conditions: Myocardial Infarct

Treatments: Drug: Ramipril Oral Product; Drug: Bisoprolol Oral Tablet; Drug: Dapagliflozin Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT06562582

2024-511789-35-00

Details and patient eligibility

About

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)

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 6 patient groups

Bisoprolol

Active Comparator group

Description:

Bisoprolol within 24 hours of PCI

Treatment:

Drug: Bisoprolol Oral Tablet

No Bisoprolol

No Intervention group

Description:

no beta blocker until day 7±12 hours

Ramipril

Active Comparator group

Description:

Ramipril within 24 hours of PCI

Treatment:

Drug: Ramipril Oral Product

No Ramipril

No Intervention group

Description:

no ramipril until day 7±12 hours after PCI

Dapagliflozin

Active Comparator group

Description:

Dapagliflozin within 24 hours versus

Treatment:

Drug: Dapagliflozin Oral Product

No Dapagliflozin

No Intervention group

Description:

no dapagliflozin treatment until day 7±12 hours after PCI