Acute Myocardial Infarction MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Jardiance®
Product Name: Empagliflozin
Product Code: BI 10773
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Current Sponsor code: BI 10
Sponsors
Boehringer Ingelheim International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital MI as qualifying event, randomisation 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 hospitalisation. OR b) Newly developed LVEF 65 years - Newly developed LVEF 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 hospitalisation - Uric acid >7.5 mg/dL (>446 µmol/L), measured at any time during hospitalisation - Pulmonary Artery 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1325 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1987
Exclusion criteria
Exclusion criteria: • Diagnosis of chronic 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 < 30 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this event-driven trial is to demonstrate the superiority of empagliflozin 10 mg once daily versus placebo, in addition to standard of care, for the reduction of the composite endpoint of time to first heart failure hospitalisation or all-cause mortality in high-risk patients hospitalised for acute MI.;Secondary Objective: Not applicable;Primary end point(s): • Composite of time to first HHF or all-cause mortality ;Timepoint(s) of evaluation of this end point: 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 |
|---|---|
| Secondary end point(s): • Total number of HHF or all-cause mortality • Total number of non-elective CV hospitalization or all-cause mortality • Total number of non-elective all-cause hospitalisation or all-cause mortality • Total number of hospitalisation for MI or all-cause mortality;Timepoint(s) of evaluation of this end point: 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, Czechia, Denmark, France, Germany, Hungary, India, Israel, Korea, Democratic People's Republic of, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Ukraine, United States
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed