Trial Condition(s):
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)
16673
Not Available
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.
- 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
Locations | |
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Locations Investigative Site Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dortmund, Germany, 44137 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergamo, Italy, 24127 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Milano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Monza-Brianza, Italy, 20090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 4, Czech Republic, 140 21 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kladno, Czech Republic, 27259 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 10, Czech Republic, 100 34 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 5, Czech Republic, 150 06 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 5, Czech Republic, 150 30 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Babio - Beade, Spain, 36312 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9103102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
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