Myocardial InfarctPhase 4STAMI-BASNCT06562582
STunning in Acute Myocardial Infarction - BAS
A Phase 4 study testing Bisoprolol Oral Tablet, Ramipril Oral Product and Dapagliflozin Oral Product in people with Myocardial Infarct, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarct
- What is being tested?
- Bisoprolol Oral Tablet, Ramipril Oral Product and Dapagliflozin Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 6 Jan 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: 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)
Read the 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
- Conditions
- Myocardial Infarct
- Being tested
- Bisoprolol Oral Tablet, Ramipril Oral Product, Dapagliflozin Oral Product
- Keywords
- ST infarction, PCI, Bisoprolol, Ramipril, Dapagliflozin, Global longitudinal strain (GLS, %)
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisoprolol Oral TabletDrug
Also called Betablocker
Timing of drug intervention after PCI
Ramipril Oral ProductDrug
Also called ACE inhibitor
Timing of drug intervention after PCI
Dapagliflozin Oral ProductDrug
Also called SGLT2 inhibitor
Timing of drug intervention after PCI
| Study group | Role | What they receive |
|---|---|---|
| Bisoprolol | Active comparator | Bisoprolol within 24 hours of PCI Receives: Drug: Bisoprolol Oral Tablet |
| No Bisoprolol | No intervention | no beta blocker until day 7±12 hours |
| Ramipril | Active comparator | Ramipril within 24 hours of PCI Receives: Drug: Ramipril Oral Product |
| No Ramipril | No intervention | no ramipril until day 7±12 hours after PCI |
| Dapagliflozin | Active comparator | Dapagliflozin within 24 hours versus Receives: Drug: Dapagliflozin Oral Product |
| No Dapagliflozin | No intervention | no dapagliflozin treatment until day 7±12 hours after PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Global longitudinal strain (GLS, %)
GLS adjusted for baseline.
Measured: day 7±24 hours
Secondary outcomes (4)
Measurement of Left ventricular ejection fraction (LVEF)
LVEF adjusted for baseline
Measured: day 7±24 hours
Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )
NT-proBNP adjusted for baseline
Measured: day 7±24 hours
Concentration of cardiac troponin-T
Area under the curve
Measured: Day 30
Concentration of cardiac troponin-I
Area under the curve
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start6 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This prospective, 2x2x2 factorial, randomized, controlled,
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Björn Redfors, Professor, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562582
- Sponsor's protocol ID
- 2024-511789-35-00
- Acronym
- STAMI-BAS
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STunning in Acute Myocardial Infarction - Beta Blockers, Angiotensin Converting Enzyme Inhibitors and Sodium/Glucose Cotransporter 2 Inhibitors Trial A Low Intervention Clinical Tria
- ClinicalTrials.gov ID
- NCT06562582
- Acronym / sponsor ID
- STAMI-BAS / 2024-511789-35-00
- Conditions
- Myocardial Infarct
- Keywords
- ST infarction, PCI, Bisoprolol, Ramipril, Dapagliflozin, Global longitudinal strain (GLS, %)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This prospective, 2x2x2 factorial, randomized, controlled,
| Arm | Type | Receives |
|---|---|---|
| Bisoprolol | Active comparator | Drug: Bisoprolol Oral TabletBisoprolol within 24 hours of PCI |
| No Bisoprolol | No intervention | –no beta blocker until day 7±12 hours |
| Ramipril | Active comparator | Drug: Ramipril Oral ProductRamipril within 24 hours of PCI |
| No Ramipril | No intervention | –no ramipril until day 7±12 hours after PCI |
| Dapagliflozin | Active comparator | Drug: Dapagliflozin Oral ProductDapagliflozin within 24 hours versus |
| No Dapagliflozin | No intervention | –no dapagliflozin treatment until day 7±12 hours after PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)
- Informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisoprolol Oral TabletAlso: BetablockerTiming of drug intervention after PCI | Drug | Bisoprolol |
| Ramipril Oral ProductAlso: ACE inhibitorTiming of drug intervention after PCI | Drug | Ramipril |
| Dapagliflozin Oral ProductAlso: SGLT2 inhibitorTiming of drug intervention after PCI | Drug | Dapagliflozin |
Primary outcome
Measurement of Global longitudinal strain (GLS, %)
Time frame: day 7±24 hours
GLS adjusted for baseline.
4 secondary outcomes
Measurement of Left ventricular ejection fraction (LVEF)
Time frame: day 7±24 hours
Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )
Time frame: day 7±24 hours
Concentration of cardiac troponin-T
Time frame: Day 30
Concentration of cardiac troponin-I
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
Related trials for Myocardial Infarct
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Björn Redfors, Professor principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisoprolol Oral Tablet, Ramipril Oral Product and Dapagliflozin Oral Product in people with Myocardial Infarct, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Björn Redfors, Professor (+46 31342100, bjoern.redfors@wlab.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Global longitudinal strain (GLS, %) (time frame: day 7±24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.