Clinical Research Details

Clinical Research

EMPACT-MI: A streamlined, multicentre, randomised, parallel group, double-blind placebo-controlled superiority trial to evaluate the effect of EMPAgliflozin on hospitalisation for heart failure and mortality in patients with aCuTe Myocardial Infarction (20203231)

Study Description

The purpose of this trial is to find out if a drug called empagliflozin, in addition to normal care, will reduce the risk of heart failure and death in patients who are hospitalized for acute MI.

Inclusion/Exclusion Criteria

Main Inclusion Criteria:
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
• Diagnosis of acute MI (type 1 per the Universal Definition of Myocardial Infarction [R20-0005]): STEMI or NSTEMI with randomization to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital MI as qualifying event, randomization must still occur within 14 days of hospital admission.

• 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 hospitalization.

OR
b) Newly developed LVEF < 45% as measured by echocardiography, ventriculography, cardiac CT, MRI or radionuclide imaging during index hospitalization.

• 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
- eGFR < 60 ml/min/1.73m2 (according to creatinine from most recent local lab during the index hospitalization and calculated with the CKD-EPI formula)
- Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI)
- Type 2 diabetes mellitus (prior or new diagnosis)
- NTproBNP >1,400 pg/mL for patients in sinus rhythm, >2,800 pg/mL if atrial fibrillation; BNP >350 pg/mL for patients in sinus rhythm, >700 pg/mL if atrial fibrillation, measured at any time during hospitalization
- Uric acid >7.5 mg/dL (>446 μmol/L), measured at any time during hospitalization
- Pulmonary Artery Systolic Pressure >40 mmHg (non-invasive [usually obtained from clinically indicated post-MI echocardiography] or invasive, at any time during hospitalization)
- 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)

 

Main Exclusion Criteria:

• Diagnosis of chronic HF prior to index MI
• Systolic blood pressure < 90 mmHg at randomization

• 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 hospitalisation) or on dialysis
• Type I diabetes mellitus
• History of ketoacidosis

 

 

Investigators