This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI. Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.
At Inclusion Visit (Visit 2 \[within 72 hours after acute MI\]), subjects will be randomly assigned to 1 of the following 3 treatment groups in a 1:1:1 ratio: * Group 1: Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks * Group 2: Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks * Group 3: Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks Then subjects will undergo study procedures at Titration Visit (Visit 3 \[Day 14\]), Treatment Visit (Visit 4 Day 42\]) and End-of-Treatment Visit (Visit 5 \[Day 84\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
295
1 or 2 capsules administered orally, twice daily
1 or 2 capsules administered orally, twice daily
Groupe Hospitalier Pitie-Salpêtrière - Institut de Cardiologie
Paris, France
UKSH Kiel
Kiel, Germany
Central Hospital of Hungarian Army
Budapest, Hungary
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Poland
NUSCH Bratislava Dpt. of Acute Cardiology
Bratislava, Slovakia
Hospital La Paz,
Madrid, Spain
Freeman Hospital Newcastle upon Tyne
Newcastle, United Kingdom
Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI)
Comparison of the effects of BID oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in LVEF on Day 84
Time frame: 84 days
Left-ventricle End-diastolic Volume Assessed by CMRI
Comparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in left-ventricle end-diastolic volume
Time frame: 84 days
Left-ventricle End-systolic Volume Assessed by CMRI
Comparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in left-ventricle end-systolic volume
Time frame: 84 days
Major Cardiac Event (MACE): Combined Clinical Endpoint of Cardiovascular Death, MI, and Cardiac Hospitalization
Comparison of the effects of BID administration of firibastat and ramipril on major cardiac event (MACE) over 84 days
Time frame: 84 days
N-terminal Pro B-type Natriuretic Peptide (NT proBNP)
Comparison of the effects of BID administration of firibastat and ramipril on the change from Baseline to Day 84 in N-terminal pro b-type natriuretic peptide (NT proBNP)
Time frame: 84 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.