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CHIARA MIA 2: A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY 1142524 in Patients After Acute Myocardial Infarction With Left-ventricular Dysfunction

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT02976467
Collaborator
(none)
107
Enrollment
25
Locations
2
Arms
20.1
Actual Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fulacimstat (BAY1142524)
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 30, 2016
Actual Primary Completion Date :
Jul 31, 2018
Actual Study Completion Date :
Sep 4, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in left-ventricular ejection fraction (LVEF) [At 6 months]

  2. Change in end diastolic volume index (EDVI) [At 6 months]

  3. Change in end systolic volume index (ESVI) [At 6 months]

Secondary Outcome Measures

  1. Number of patients with adverse events [Up to 7 months]

  2. Number of patients with serious adverse events [Up to 7 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kladno Czechia 27259
2 Praha 10 Czechia 100 34
3 Praha 4 Czechia 140 21
4 Praha 5 Czechia 150 06
5 Praha 5 Czechia 150 30
6 Hannover Niedersachsen Germany 30625
7 Dortmund Nordrhein-Westfalen Germany 44137
8 Erfurt Thüringen Germany 99089
9 Berlin Germany 13353
10 Beer Sheva Israel 8410101
11 Haifa Israel 3109601
12 Jerusalem Israel 9103102
13 Jerusalem Israel 9112001
14 Petah Tikva Israel 4941492
15 Tel Aviv Israel 6423906
16 Bergamo Lombardia Italy 24127
17 Brescia Lombardia Italy 25123
18 Milano Lombardia Italy 20089
19 Milano Lombardia Italy 20138
20 Monza-Brianza Lombardia Italy 20090
21 Babio - Beade Pontevedra Spain 36312
22 Barcelona Spain 08036
23 Madrid Spain 28007
24 Madrid Spain 28040
25 Valencia Spain 46026

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02976467
Other Study ID Numbers:
  • 16673
  • 2016-002167-33
First Posted:
Nov 29, 2016
Last Update Posted:
Sep 3, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Fulacimstat

Study Results

No Results Posted as of Sep 3, 2019