Health Condition 1: I219- Acute myocardial infarction, unspecified
Conditions
Interventions
Intervention1: Empagliflozin: 10 mg film-coated tablet once daily orally until withdrawal by patient or Investigator, or completion of the endpoint-driven trial by Sponsor
Control Intervention1: Place
Sponsors
Boehringer Ingelheim International GmbH
Labcorp Drug Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 2. Diagnosis of spontaneous acute myocardial infarction (AMI): STEMI or NSTEMI with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an inhospital MI as qualifying event, randomisation must still occur within 14 days of hospital admission. Spontaneous AMI is defined as MI with a primary etiology of an acute coronary artery disease pathology (e.g., plaque rupture/erosion, in-stent restenosis, stent thrombosis) rather than MI caused by supply demand mismatch (e.g., sepsis, arrhythmia, anemia, or other condition). Spontaneous AMI is established when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia due to primary coronary event. Under these conditions, the following criteria have to be met for the diagnosis of spontaneous AMI: Detection of rise and/or fall of cardiac enzymes (cardiac troponin, cTn or the MB fraction of creatinine kinase, CKMB) with at least one value above the 99th percentile of the upper reference limit (URL) or the local laboratory MI diagnosis cut-off value, together with evidence of myocardial ischemia with at least one of the following: • Ischemic discomfort or other ischemia symptom(s) • Electrocardiogram (ECG) characteristics of STEMI or NSTEMI including new or presumably new significant ST- segment-T wave (ST-T) changes • Newly developed pathological Q waves or left bundle branch block (LBBB) in the ECG • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology • Identification of a coronary thrombus by angiography 3. High risk of HF, defined as EITHER a) Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalisation. OR b) Newly developed LVEF 4. In addition, at least one of risk factors such as: - Age > 65 years - Newly developed LVEF - Prior MI (before index MI) documented in medical records - Estimated Glomerular Filtration Rate (eGFR) - Atrial fibrillation (persistent or permanent; if paroxysmal, only valid if associated with index MI) - Type 2 diabetes mellitus (prior or new diagnosis) - N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) >1,400 pg/mL for patients in sinus rhythm, >2,800 pg/mL if atrial fibrillation; Brain Natriuretic Peptide (BNP) >350 pg/mL for patients in sinus rhythm, >700 pg/mL if atrial fibrillation, measured at any time during hospitalisation - Uric acid >7.5 mg/dL ( >446 μmol/L), measured at any ti
Exclusion criteria
Exclusion criteria: 1. Diagnosis of chronic heart failure prior to index MI 2. Systolic blood pressure 3. Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomization 4. Coronary Artery Bypass Grafting planned at time of randomisation 5. Current diagnosis of Takotsubo cardiomyopathy 6. Any current severe (stenotic or regurgitant) valvular heart disease 7. eGFR 8. Type I diabetes mellitus. Further exclusion criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of time to first hospitalization for heart failure or all-cause mortalityTimepoint: At randomized treatment period Visits 2, 3, 4, 5-8 and end of study, from the day of first randomization until the total number of patients with investigator reported primary endpoint events reaches a target of 532. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to CV mortalityTimepoint: At randomized treatment period Visits 2, 3, 4, 5-8 and end of study, from the day of first randomization until the total number of patients with investigator reported primary endpoint events reaches a target of 532.;Total number of HHF or all-cause mortalityTimepoint: At randomized treatment period Visits 2, 3, 4, 5-8 and end of study, from the day of first randomization until the total number of patients with investigator reported primary endpoint events reaches a target of 532.;Total number of hospitalisation for MI or all-cause mortalityTimepoint: At randomized treatment period Visits 2, 3, 4, 5-8 and end of study, from the day of first randomization until the total number of patients with investigator reported primary endpoint events reaches a target of 532.;Total number of non-elective all-cause hospitalisation or all-cause mortalityTimepoint: At randomized treatment period Visits 2, 3, 4, 5-8 and end of study, from the day of first randomization until the total number of patients with investigator reported primary endpoint events reaches a target of 532.;Total number of non-elective CV hospitalization or all-cause mortalityTimepoint: At randomized treatment period Visits 2, 3, 4, 5-8 and end of study, from the day of first randomization until the total number of patients with investigator reported primary endpoint events reaches a target of 532. | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Denmark, France, Germany, Hungary, India, Israel, Japan, Netherlands, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Spain, Ukraine, United States of America
Contacts
Public ContactShekhar Dawkhar
Labcorp Drug Development India Pvt. Ltd
Outcome results
None listed