To evaluate the hypothesis that a fast discharge strategy (discharge at 24 \[± 12\] hours) following invasive management for acute myocardial infarction is non-inferior to standard of care (\>36 hours) with respect to the risk of major adverse cardiovascular events (MACE) during follow-up.
The goal of this randomized, multicenter trial is to assess the safety of a fast discharge strategy following acute myocardial infarction as compared to standard of care. The trial will evaluate the hypothesis that a fast discharge strategy (discharge at 24 \[± 12\] hours) following invasive management of acute myocardial infarction is non-inferior to standard of care (discharge \>36 hours) with respect to the risk of major adverse cardiovascular events at 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
2,070
Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria
RECRUITINGCardinal Schwarzenberg Hospital Schwarzach
Schwarzach im Pongau, Schwarzach Im Pongau, Austria
NOT_YET_RECRUITINGParacelsus Medical University Salzburg
Salzburg, State of Salzburg, Austria
MACE
MACE is defined as a composite of all-cause death, myocardial re-infarction and unscheduled cardiovascular re-hospitalization.
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
All cause death
Death from any cause.
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Number of participants with myocardial re-infarction
Number of participants experiencing myocardial re-infarction
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Number of participants with unscheduled cardiovascular re-hospitalization
Number of participants with unscheduled cardiovascular re-hospitalization
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Number of participants with Cardiovascular death
Number of participants experiencing cardiovascular-related death
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Number of participants hospitalized for heart failure
Number of participants hospitalized for heart failure
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Number of participants expiring hospitalization from any cause
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Medical University of Graz
Graz, Styria, Austria
RECRUITINGMedical University of Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGUniversity Teaching Hospital Wels-Grieskirchen
Wels, Upper Austria, Austria
RECRUITINGAcademic Teaching Hospital Feldkirch
Feldkirch, Vorarlberg, Austria
RECRUITINGLudwig Maximilian University Munich
Munich, Bavaria, Germany
NOT_YET_RECRUITINGNumber of participants expiring hospitalization from any cause
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Number of patients experiencing a stroke
Number of patients experiencing a stroke
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Number of participants with a bleeding event
Number of participants with a bleeding event
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Healthcare costs per patient between randomization and 12 months
An economic evaluation will be conducted from the healthcare payer perspective. Direct healthcare costs, including intervention costs, hospitalizations, outpatient visits, diagnostic procedures, and concomitant medications, will be collected prospectively for each participant over the study period. Mean total healthcare costs per patient will be calculated and compared between study groups.
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Length of hospital stay
Number of days in hospital from time of infarction to hospital discharge
Time frame: From the date of randomization to the date of hospital discharge, for up to 100 days
Percentage of patients on guideline-directed therapy
Percentage of patients on guideline-directed therapy
Time frame: From the date of randomization until the first documented event during the follow-up period (up to 12 months).
Infection
Infection leading to hospitalization
Time frame: At 30 days