NCT02976467

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2016

Geographic Reach
5 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2018

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

November 24, 2016

Last Update Submit

August 30, 2019

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

  • Change in left-ventricular ejection fraction (LVEF)

    At 6 months

  • Change in end diastolic volume index (EDVI)

    At 6 months

  • Change in end systolic volume index (ESVI)

    At 6 months

Secondary Outcomes (2)

  • Number of patients with adverse events

    Up to 7 months

  • Number of patients with serious adverse events

    Up to 7 months

Study Arms (2)

Fulacimstat (BAY1142524)

EXPERIMENTAL

30 patients with left-ventricular dysfunction after acute myocardial infarction

Drug: Fulacimstat (BAY1142524)

Placebo

PLACEBO COMPARATOR

30 patients with left-ventricular dysfunction after acute myocardial infarction

Drug: Placebo

Interventions

Fulacimstat (BAY1142524)DRUG

25 mg BAY 1142524 are given twice daily over a treatment period of 6 months

Fulacimstat (BAY1142524)
PlaceboDRUG

Matching placebo tablets are given twice daily over a treatment period of 6 months

Placebo

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Unknown Facility

Kladno, 27259, Czechia

Location

Unknown Facility

Prague, 100 34, Czechia

Location

Unknown Facility

Prague, 140 21, Czechia

Location

Unknown Facility

Prague, 150 06, Czechia

Location

Unknown Facility

Prague, 150 30, Czechia

Location

Unknown Facility

Hanover, Lower Saxony, 30625, Germany

Location

Unknown Facility

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

Unknown Facility

Erfurt, Thuringia, 99089, Germany

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Beersheba, 8410101, Israel

Location

Unknown Facility

Haifa, 3109601, Israel

Location

Unknown Facility

Jerusalem, 9103102, Israel

Location

Unknown Facility

Jerusalem, 9112001, Israel

Location

Unknown Facility

Petah Tikva, 4941492, Israel

Location

Unknown Facility

Tel Aviv, 6423906, Israel

Location

Unknown Facility

Bergamo, Lombardy, 24127, Italy

Location

Unknown Facility

Brescia, Lombardy, 25123, Italy

Location

Unknown Facility

Milan, Lombardy, 20089, Italy

Location

Unknown Facility

Milan, Lombardy, 20138, Italy

Location

Unknown Facility

Monza-Brianza, Lombardy, 20090, Italy

Location

Unknown Facility

Babio - Beade, Pontevedra, 36312, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Madrid, 28007, Spain

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Valencia, 46026, Spain

Location

Related Publications (1)

  • Duengen HD, Kim RJ, Zahger D, Orvin K, Kornowski R, Admon D, Kettner J, Shimony A, Otto C, Becka M, Kanefendt F, Romo AI, Hasin T, Ostadal P, Rojas GC, Senni M; GROUP investigators of the CHIARA MIA 2 trial. Effects of the chymase inhibitor fulacimstat on adverse cardiac remodeling after acute myocardial infarction-Results of the Chymase Inhibitor in Adverse Remodeling after Myocardial Infarction (CHIARA MIA) 2 trial. Am Heart J. 2020 Jun;224:129-137. doi: 10.1016/j.ahj.2020.01.012. Epub 2020 Jan 25.

    PMID: 32375104DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

fulacimstat

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

November 29, 2016

Study Start

December 30, 2016

Primary Completion

July 31, 2018

Study Completion

September 4, 2018

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

IT(5)DE(4)ES(5)IL(6)CZ(5)