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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002167-33 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fulacimstat (BAY1142524) | Experimental | 30 patients with left-ventricular dysfunction after acute myocardial infarction |
|
| Placebo | Placebo Comparator | 30 patients with left-ventricular dysfunction after acute myocardial infarction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulacimstat (BAY1142524) | Drug | 25 mg BAY 1142524 are given twice daily over a treatment period of 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in left-ventricular ejection fraction (LVEF) | At 6 months | |
| Change in end diastolic volume index (EDVI) | At 6 months | |
| Change in end systolic volume index (ESVI) | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | Up to 7 months | |
| Number of patients with serious adverse events | Up to 7 months |
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Inclusion Criteria:
Patients with first ST elevation myocardial infarction (STEMI) treated with primary percutaneous intervention (PCI) or thrombolysis within 24 hours after symptom onset
Diagnosis of STEMI requires the presence of the following three criteria:
At the screening period, on day 5 to 9 after MI, patients have to have a LVEF ≤ 45% and an infarct size >10% LV mass (as measured by LGE-MRI, central-blinded evaluation)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kladno | 27259 | Czechia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32375104 | Derived | Duengen HD, Kim RJ, Zahger D, Orvin K, Kornowski R, Admon D, Kettner J, Shimony A, Otto C, Becka M, Kanefendt F, Romo AI, Hasin T, Ostadal P, Rojas GC, Senni M; GROUP investigators of the CHIARA MIA 2 trial. Effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute myocardial infarction-Results of the Chymase Inhibitor in Adverse Remodeling after Myocardial Infarction (CHIARA MIA) 2 trial. Am Heart J. 2020 Jun;224:129-137. doi: 10.1016/j.ahj.2020.01.012. Epub 2020 Jan 25. |
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| Placebo | Drug | Matching placebo tablets are given twice daily over a treatment period of 6 months |
|
| Prague |
| 100 34 |
| Czechia |
| Prague | 140 21 | Czechia |
| Prague | 150 06 | Czechia |
| Prague | 150 30 | Czechia |
| Hanover | Lower Saxony | 30625 | Germany |
| Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Erfurt | Thuringia | 99089 | Germany |
| Berlin | 13353 | Germany |
| Beersheba | 8410101 | Israel |
| Haifa | 3109601 | Israel |
| Jerusalem | 9103102 | Israel |
| Jerusalem | 9112001 | Israel |
| Petah Tikva | 4941492 | Israel |
| Tel Aviv | 6423906 | Israel |
| Bergamo | Lombardy | 24127 | Italy |
| Brescia | Lombardy | 25123 | Italy |
| Milan | Lombardy | 20089 | Italy |
| Milan | Lombardy | 20138 | Italy |
| Monza-Brianza | Lombardy | 20090 | Italy |
| Babio - Beade | Pontevedra | 36312 | Spain |
| Barcelona | 08036 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28040 | Spain |
| Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C000709182 | fulacimstat |
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