Myocardial Infarction
Conditions
Interventions
Patient will receive medication (IP) in addition to the stnadard treatment -
tablets to be taken daily.
the study visits are at the hospital, though some are online (via app or
computer), for which
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion 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 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 [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 criteria
Exclusion criteria: Main Exclusion Criteria: 1) Diagnosis of chronic HF prior to index MI 2) Systolic blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: • Composite of time to first HHF or all-cause mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints which are part of the testing strategy: • 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 Other secondary endpoints: • Time to CV mortality | — |
Countries
Netherlands
Outcome results
None listed