E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Left-ventricular dysfunction after acute myocardial infarction |
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E.1.1.1 | Medical condition in easily understood language |
Left-ventricular dysfunction after acute myocardial infarction |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to determine efficacy of BAY 1142524 by investigating the changes in LVEF, EDVI, and ESVI from baseline to 6 months after treatment with 25 mg of BAY 1142524 BID in comparison to placebo and on top of standard of care as measured by cardiac MRI |
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E.2.2 | Secondary objectives of the trial |
Secondary objective is to analyze safety and tolerability as evidenced by the incidence and severity of AEs |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with first ST elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) or thrombolysis within 24 h after symptom onset. 2. Diagnosis of STEMI requires the presence of the following 3 criteria: * Typical clinical symptoms such as chest pain, shortness of breath for more than 20 min related to the myocardial infarction. * New ST elevation indicating myocardial infarction * Significant elevation in troponin T or I with at least one value above the 99th percentile upper reference limit (URL) and / or elevation of creatinine kinase (CK) and creatinine kinase MB (6-10% of CK-MB). 3. 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). |
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E.4 | Principal exclusion criteria |
1. Contraindication to perform MRI. 2. LVEF < 20%. 3. Previous MI, previous cardiac surgery such as CABG. 4. History of heart failure or LVEF < 50% before occurrence of the first STEMI. 5. Infarct size > 45% (g/g; LV mass) between 5 and 9 days after acute MI. 6. NYHA class IV at randomization. 7. Any planned cardiac intervention after baseline MRI or any other planned operations. 8. Non-ischemic causes for cardiomyopathy 9. Diagnosis of atrial Fibrillation 10. Systolic blood pressure < 100 mmHg or > 180 mmHg; diastolic blood pressure < 50 mmHg or > 110 mmHg; heart rate < 50 or > 100 beats / min 11. Most recent eGFR result since MI < 30 mL/min/1.73m2 12. Clinically relevant hepatic dysfunction |
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E.5 End points |
E.5.1 | Primary end point(s) |
The change in LVEF, EDVI, and ESVI from baseline to 6 months of treatment with 25 mg of BAY 1142524 BID |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
LVEF, EDVI, and ESVI will be assessed by cardiac MRI (at baseline) during the screening period (5 to 9 days after acute MI) and after 6 months of treatment (visit 4) |
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E.5.2 | Secondary end point(s) |
Number and severity of treatment emergent adverse event (TEAE) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From the first study drug administration until 7 days after the stop of study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Czech Republic |
Germany |
Israel |
Italy |
Spain |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 9 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 9 |