A Phase 2 interventional study of Fulacimstat (BAY1142524) and Placebo in Myocardial Infarction, sponsored by Bayer. Completed at 25 sites in 5 countries. Open to participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-09-03.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 107 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of STEMI requires the presence of the following three criteria:
Exclusion Criteria:
30 patients with left-ventricular dysfunction after acute myocardial infarction
Drug: Fulacimstat (BAY1142524)
30 patients with left-ventricular dysfunction after acute myocardial infarction
Drug: Placebo
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
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
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bayer