Status:
COMPLETED
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)
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Diagnosis of chronic Heart Failure (HF) prior to index MI.
- 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.
- Any current severe (stenotic or regurgitant) valvular heart disease.
- eGFR \< 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
- Type I diabetes mellitus. Further exclusion criteria apply.
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2023
Estimated Enrollment :
6522 Patients enrolled
Trial Details
Trial ID
NCT04509674
Start Date
December 16 2020
End Date
November 5 2023
Last Update
January 7 2025
Active Locations (439)
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1
Advanced Cardiovascular LLC
Alexander City, Alabama, United States, 35010
2
Grandview Medical Center
Birmingham, Alabama, United States, 35243
3
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
4
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297