STunning in Acute Myocardial Infarction - BAS
STAMI-BAS
1 other identifier
interventional
120
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2025
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2024
CompletedFirst Posted
Study publicly available on registry
August 20, 2024
CompletedStudy Start
First participant enrolled
January 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 27, 2025
August 1, 2024
3 years
August 16, 2024
June 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of Global longitudinal strain (GLS, %)
GLS adjusted for baseline.
day 7±24 hours
Secondary Outcomes (4)
Measurement of Left ventricular ejection fraction (LVEF)
day 7±24 hours
Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide )
day 7±24 hours
Concentration of cardiac troponin-T
Day 30
Concentration of cardiac troponin-I
Day 30
Other Outcomes (1)
Measurement of Infarct size
Day 30
Study Arms (6)
Bisoprolol
ACTIVE COMPARATORBisoprolol within 24 hours of PCI
No Bisoprolol
NO INTERVENTIONno beta blocker until day 7±12 hours
Ramipril
ACTIVE COMPARATORRamipril within 24 hours of PCI
No Ramipril
NO INTERVENTIONno ramipril until day 7±12 hours after PCI
Dapagliflozin
ACTIVE COMPARATORDapagliflozin within 24 hours versus
No Dapagliflozin
NO INTERVENTIONno dapagliflozin treatment until day 7±12 hours after PCI
Interventions
Timing of drug intervention after PCI
Eligibility Criteria
You may qualify if:
- Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2024
First Posted
August 20, 2024
Study Start
January 6, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
June 27, 2025
Record last verified: 2024-08