The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI). BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in functional parameters of adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection fraction). Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 30 patients have to complete treatment with verum and 30 patients have to complete treatment with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
107
25 mg BAY 1142524 are given twice daily over a treatment period of 6 months
Matching placebo tablets are given twice daily over a treatment period of 6 months
Unnamed facility
Kladno, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Hanover, Lower Saxony, Germany
Unnamed facility
Dortmund, North Rhine-Westphalia, Germany
Unnamed facility
Erfurt, Thuringia, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Beersheba, Israel
...and 15 more locations
Change in left-ventricular ejection fraction (LVEF)
Time frame: At 6 months
Change in end diastolic volume index (EDVI)
Time frame: At 6 months
Change in end systolic volume index (ESVI)
Time frame: At 6 months
Number of patients with adverse events
Time frame: Up to 7 months
Number of patients with serious adverse events
Time frame: Up to 7 months
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