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.

A randomized, double-blind multicenter study to assess the safety and efficacy of a six month oral treatment with the chymase inhibitor BAY 1142524 at a dose of 25 mg BID in comparison to placebo on top of standard of care in patients with reduced left-ventricular ejection fraction (LVEF = 45%) after acute myocardial infarction (CHIARA MIA 2). - Chymase inhibitor BAY 1142524 in left-ventricular dysfunction after acute myocardial infarction.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002167-33-CZ

Enrollment

207

Registered

2016-08-22

Start date

2016-11-23

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left-ventricular dysfunction after acute myocardial infarction

Interventions

Product Name: BAY1142524 25mg tablets Product Code: BAY1142524 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: not yet assigned Current Sponsor code: BAY 1142524 Other descriptive name: B

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)	—

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): 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 study	—

Countries

Czech Republic, Germany, Israel, Italy, Spain

Contacts

Public ContactClinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026