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)

August 30, 2019 updated by: Bayer

A Randomized, Double-blind, Multicenter Study to Assess the Safety and Efficacy of a 6 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Kladno, Czechia, 27259
      • Praha 10, Czechia, 100 34
      • Praha 4, Czechia, 140 21
      • Praha 5, Czechia, 150 06
      • Praha 5, Czechia, 150 30
  • Germany
      • Berlin, Germany, 13353
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Dortmund, Nordrhein-Westfalen, Germany, 44137
    • Thüringen
      • Erfurt, Thüringen, Germany, 99089
  • Israel
      • Beer Sheva, Israel, 8410101
      • Haifa, Israel, 3109601
      • Jerusalem, Israel, 9112001
      • Jerusalem, Israel, 9103102
      • Petah Tikva, Israel, 4941492
      • Tel Aviv, Israel, 6423906
  • Italy
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
      • Brescia, Lombardia, Italy, 25123
      • Milano, Lombardia, Italy, 20089
      • Milano, Lombardia, Italy, 20138
      • Monza-Brianza, Lombardia, Italy, 20090
  • Spain
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28040
      • Madrid, Spain, 28007
      • Valencia, Spain, 46026
    • Pontevedra
      • Babio - Beade, Pontevedra, Spain, 36312

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fulacimstat (BAY1142524)
30 patients with left-ventricular dysfunction after acute myocardial infarction
Drug: Fulacimstat (BAY1142524)
25 mg BAY 1142524 are given twice daily over a treatment period of 6 months
Placebo Comparator: Placebo
30 patients with left-ventricular dysfunction after acute myocardial infarction
Drug: Placebo
Matching placebo tablets are given twice daily over a treatment period of 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in left-ventricular ejection fraction (LVEF)
Time Frame: At 6 months
At 6 months
Change in end diastolic volume index (EDVI)
Time Frame: At 6 months
At 6 months
Change in end systolic volume index (ESVI)
Time Frame: At 6 months
At 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: Up to 7 months
Up to 7 months
Number of patients with serious adverse events
Time Frame: Up to 7 months
Up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2016

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

September 4, 2018

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

November 24, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16673
  • 2016-002167-33 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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