EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

Korábbi kezelés

• Diagnosis of chronic Heart Failure (HF) prior to index MI.

Más betegség

• Any current severe (stenotic or regurgitant) valvular heart disease.
• Type I diabetes mellitus. Further exclusion criteria apply.

Laborértékek

• eGFR < 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.

Egyéb

• Systolic blood pressure < 90 mmHg at randomisation.
• Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
• Coronary Artery Bypass Grafting planned at time of randomisation.
• Current diagnosis of Takotsubo cardiomyopathy.

• Of full age of consent (according to local legislation, at least ≥ 18 years) at screening.
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
• Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
• Diagnosis of spontaneous Acute Myocardial Infarction (AMI): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital Myocardial Infarction (MI) as qualifying event, randomization must still occur within 14 days of hospital admission.
• High risk of HF, defined as EITHER
  • 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 hospitalization.
  • OR
  • Newly developed Left Ventricular Ejection Fraction (LVEF) < 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation.
• In addition at least one of the following risk factors:
  • Age > 65 years,
  • Newly developed LVEF < 35%,
  • Prior MI (before index MI) documented in medical records,
  • Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) formula based on creatinine from local lab at any time during index hospitalisation),
  • 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 time during hospitalisation,
  • Pulmonary Artery Systolic Pressure [or right ventricular systolic pressure] >40 mmHg (non-invasive [usually obtained from clinically indicated post-MI echocardiography] or invasive, at any time during hospitalisation),
  • Patient not revascularized (and no planned revascularization) for the index MI (Includes e.g. patients where no angiography is performed, unsuccessful revascularization attempts, diffuse atherosclerosis not amenable for intervention; but does NOT include if revascularization was not performed due to nonobstructive coronary arteries),
  • 3-vessel coronary artery disease at time of index MI,
  • Diagnosis of peripheral artery disease (extracoronary vascular disease, e.g. lower extremity artery disease or carotid artery disease).