Back to resultsA 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)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fulacimstat (BAY1142524)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fulacimstat (BAY1142524)
Placebo
Arm Description
30 patients with left-ventricular dysfunction after acute myocardial infarction
30 patients with left-ventricular dysfunction after acute myocardial infarction
Outcomes
Primary Outcome Measures
Change in left-ventricular ejection fraction (LVEF)
Change in end diastolic volume index (EDVI)
Change in end systolic volume index (ESVI)
Secondary Outcome Measures
Number of patients with adverse events
Number of patients with serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02976467
Brief Title
A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction
Acronym
CHIARA MIA 2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 30, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
September 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fulacimstat (BAY1142524)
Arm Type
Experimental
Arm Description
30 patients with left-ventricular dysfunction after acute myocardial infarction
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30 patients with left-ventricular dysfunction after acute myocardial infarction
Intervention Type
Drug
Intervention Name(s)
Fulacimstat (BAY1142524)
Intervention Description
25 mg BAY 1142524 are given twice daily over a treatment period of 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets are given twice daily over a treatment period of 6 months
Primary Outcome Measure Information:
Title
Change in left-ventricular ejection fraction (LVEF)
Time Frame
At 6 months
Title
Change in end diastolic volume index (EDVI)
Time Frame
At 6 months
Title
Change in end systolic volume index (ESVI)
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Number of patients with adverse events
Time Frame
Up to 7 months
Title
Number of patients with serious adverse events
Time Frame
Up to 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Kladno
ZIP/Postal Code
27259
Country
Czechia
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
City
Praha 5
ZIP/Postal Code
150 30
Country
Czechia
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20138
Country
Italy
City
Monza-Brianza
State/Province
Lombardia
ZIP/Postal Code
20090
Country
Italy
City
Babio - Beade
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32375104
Citation
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.
Results Reference
derived
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A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction
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