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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bisoprolol | Active Comparator | Bisoprolol within 24 hours of PCI |
|
| No Bisoprolol | No Intervention | no beta blocker until day 7±12 hours | |
| Ramipril | Active Comparator | Ramipril within 24 hours of PCI |
|
| No Ramipril | No Intervention | no ramipril until day 7±12 hours after PCI | |
| Dapagliflozin | Active Comparator | Dapagliflozin within 24 hours versus |
|
| No Dapagliflozin | No Intervention | no dapagliflozin treatment until day 7±12 hours after PCI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bisoprolol Oral Tablet | Drug | Timing of drug intervention after PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Global longitudinal strain (GLS, %) | GLS adjusted for baseline. | day 7±24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Left ventricular ejection fraction (LVEF) | LVEF adjusted for baseline | day 7±24 hours |
| Measurement of NT-proBNP (N-terminal pro b-type natriuretic peptide ) | NT-proBNP adjusted for baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Infarct size | MI size assessed by CMRI (sub-study) | Day 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Björn Redfors, Professor | Contact | +46 31342100 | bjoern.redfors@wlab.gu.se | |
| Margareta Scharin Täng, PhD | Contact | 0736916467 | margareta.scharin.tang@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | 41345 | Sweden |
Plan has not be decided
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017298 | Bisoprolol |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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This prospective, 2x2x2 factorial, randomized, controlled,
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| Ramipril Oral Product | Drug | Timing of drug intervention after PCI |
|
|
| Dapagliflozin Oral Product | Drug | Timing of drug intervention after PCI |
|
|
| day 7±24 hours |
| Concentration of cardiac troponin-T | Area under the curve | Day 30 |
| Concentration of cardiac troponin-I | Area under the curve | Day 30 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |