Trial Condition(s):

Myocardial Infarction

A double-blind study to investigate efficacy, safety and tolerability of BAY 1142524 in patients after acute myocardial infarction with left-ventricular dysfunction (CHIARA MIA 2)

Bayer Identifier:

16673

ClinicalTrials.gov Identifier:

NCT02976467

EudraCT Number:

2016-002167-33

Study Completed

Trial Purpose

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.

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:
-- Typical clinical symptoms such as chest pain, shortness of breath for more than 20 minutes 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 creatine kinase (CK) and creatine kinase MB (6-10% of total CK)
- 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
- Contraindication to perform contrast-enhanced cardiac MRI
- LVEF < 20%
- History of heart failure or LVEF < 50% before occurrence of the first STEMI
- Infarct size > 45% (g/g; LV mass) between 5 and 9 days after myocardial infarction
- NYHA (New York Heart Association) class IV at randomization
- Any planned cardiac intervention after baseline  MRI or any other planned operations
- Non-ischemic causes for cardiomyopathy
- Diagnosis of atrial fibrillation
- Systolic blood pressure < 100 mm Hg or > 180 mm Hg; diastolic blood pressure < 50 mm Hg or >110 mm Hg, heart rate < 50 or >100 beat/minute; mean of triplicate values at randomization
- Clinically relevant hepatic dysfunction

Trial Summary

Enrollment Goal
107
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Fulacimstat (BAY1142524)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Berlin, Germany, 13353

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
Locations

Investigative Site

Erfurt, Germany, 99089

Status
Completed
 
Locations

Investigative Site

Dortmund, Germany, 44137

Status
Completed
 
Locations

Investigative Site

Bergamo, Italy, 24127

Status
Completed
 
Locations

Investigative Site

Brescia, Italy, 25123

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20138

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20089

Status
Completed
 
Locations

Investigative Site

Monza-Brianza, Italy, 20090

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28007

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46026

Status
Completed
 
Locations

Investigative Site

Praha 4, Czech Republic, 140 21

Status
Completed
 
Locations

Investigative Site

Kladno, Czech Republic, 27259

Status
Terminated
 
Locations

Investigative Site

Praha 10, Czech Republic, 100 34

Status
Completed
 
Locations

Investigative Site

Praha 5, Czech Republic, 150 06

Status
Completed
 
Locations

Investigative Site

Praha 5, Czech Republic, 150 30

Status
Completed
 
Locations

Investigative Site

Babio - Beade, Spain, 36312

Status
Completed
 
Locations

Investigative Site

Tel Aviv, Israel, 6423906

Status
Completed
 
Locations

Investigative Site

Petah Tikva, Israel, 4941492

Status
Completed
 
Locations

Investigative Site

Jerusalem, Israel, 9103102

Status
Completed
 
Locations

Investigative Site

Haifa, Israel, 3109601

Status
Completed
 
Locations

Investigative Site

Beer Sheva, Israel, 8410101

Status
Completed
 
Locations

Investigative Site

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28040

Status
Completed
 

Trial Design