Left-ventricular dysfunction after acute myocardial infarction
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Contraindication to perform MRI. 2. LVEF 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 180 mmHg; diastolic blood pressure 110 mmHg; heart rate 100 beats / min 11. Most recent eGFR result since MI < 30 mL/min/1.73m2 12. Clinically relevant hepatic dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Analysis of the composite of CV mortality and re-hospitalization for heart failure within 6 months of treatment 2. CV hospitalization rate within 6 months of treatment 3. Analyze the infarct size (% LV mass), and the WMS, by cardiac MRI during the screening period and after 6 months of treatment with BAY 1142524 and placebo. 4. PK analysis (see section 9.5.1 of the protocol) 5. Biomarker analysis (see section 9.5.2 of the protocol);Timepoint(s) of evaluation of this end point: 1. From baseline to 6 months of treatment 2. From baseline to 6 months of treatment 3. At baselines and after 6 months of treatment 4. See section 9.5.1 of the protocol 5. See section 9.5.2 of the protocol | — |
Countries
Czech Republic, Germany, Israel, Italy, Spain
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed