check_circleStudy Completed

Myocardial Infarction

Bayer Identifier:

16673

ClinicalTrials.gov Identifier:

NCT02976467

EudraCT Number:

2016-002167-33

EU CT Number:

Not Available
A double-blind study to investigate efficacy, safety and tolerability of BAY 1142524 in patients after acute myocardial infarction with left-ventricular dysfunction

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.

Key Participants Requirements

Sex

Both

Age

40 - 79 Years
  • - 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)
  • - 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
December 2016 - September 2018
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Fulacimstat (BAY1142524)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany
Completed
Hannover, 30625, Germany
Withdrawn
Bad Krozingen, 79189, Germany
Completed
Erfurt, 99089, Germany
Completed
Dortmund, 44137, Germany
Completed
Bergamo, 24127, Italy
Completed
Brescia, 25123, Italy
Completed
Milano, 20138, Italy
Completed
Milano, 20089, Italy
Completed
Monza-Brianza, 20090, Italy
Completed
Madrid, 28007, Spain
Completed
Valencia, 46026, Spain
Completed
Praha 4, 140 21, Czech Republic
Withdrawn
Madrid, 28041, Spain
Terminated
Kladno, 27259, Czech Republic
Completed
Praha 10, 100 34, Czech Republic
Completed
Praha 5, 150 06, Czech Republic
Completed
Praha 5, 150 30, Czech Republic
Completed
Babio - Beade, 36312, Spain
Completed
Tel Aviv, 6423906, Israel
Completed
Petah Tikva, 4941492, Israel
Completed
Jerusalem, 9103102, Israel
Completed
Haifa, 3109601, Israel
Completed
Beer Sheva, 8410101, Israel
Completed
Jerusalem, 9112001, Israel
Completed
Barcelona, 08036, Spain
Completed
Madrid, 28040, Spain

Primary Outcome

  • Change in left-ventricular ejection fraction (LVEF)
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in end diastolic volume index (EDVI)
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in end systolic volume index (ESVI)
    date_rangeTime Frame:
    At 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of patients with adverse events
    date_rangeTime Frame:
    Up to 7 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of patients with serious adverse events
    date_rangeTime Frame:
    Up to 7 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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