A study to investigate the safety and efficacy of a six month oral treatment with a twice daily dose of BAY 1142524 in comparison to placebo in patients with reduced left-ventricular ejection fraction after acute myocardial infarction.

Phase 1

Conditions: eft-ventricular dysfunction after acute myocardial infarction
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2016-002167-33-CZ

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 185

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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: Secondary objective is to analyze safety and tolerability as evidenced by the incidence and severity of AEs;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;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)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number and severity of treatment emergent adverse event (TEAE);Timepoint(s) of evaluation of this end point: From the first study drug administration until 7 days after the stop of<br>study

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