Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2025-01-06
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Bisoprolol
Bisoprolol within 24 hours of PCI
Bisoprolol Oral Tablet
Timing of drug intervention after PCI
No Bisoprolol
no beta blocker until day 7±12 hours
No interventions assigned to this group
Ramipril
Ramipril within 24 hours of PCI
Ramipril Oral Product
Timing of drug intervention after PCI
No Ramipril
no ramipril until day 7±12 hours after PCI
No interventions assigned to this group
Dapagliflozin
Dapagliflozin within 24 hours versus
Dapagliflozin Oral Product
Timing of drug intervention after PCI
No Dapagliflozin
no dapagliflozin treatment until day 7±12 hours after PCI
No interventions assigned to this group
Interventions
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Bisoprolol Oral Tablet
Timing of drug intervention after PCI
Ramipril Oral Product
Timing of drug intervention after PCI
Dapagliflozin Oral Product
Timing of drug intervention after PCI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Informed consent
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Central Contacts
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Other Identifiers
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2024-511789-35-00
Identifier Type: -
Identifier Source: org_study_id
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