Prevention of left ventricular dysfunction after acute anterior myocardial infarction
Conditions
Interventions
Product Name: Firibastat
Product Code: QGC001
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Firibastat
CAS Number: 648927-86-0
Current Sponsor code: QGC001
Concentration unit: mg milligram(s
Sponsors
Quantum Genomics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must provide signed written informed consent. Important Note: Subject must be willing and able to give informed consent for participation in the study. 2. Men and women >= 18 years of age at Screening. 3. Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as chest pain >30 minutes and ST elevation =0.2 mV in at least 2 consecutive electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1-V6). 4. Primary PCI of the index-MI-related artery within 24 hours after the MI. 5. Women of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post-dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depot, patch, or injectable), together with supplementary double-barrier methods such as condoms or diaphragms with spermicidal gel or foam. 6. Women of childbearing potential must have a negative serum pregnancy test result at the Screening Visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 147 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 147
Exclusion criteria
Exclusion criteria: 1. Body mass index >45 kg/m². 2. Subject is hemodynamically unstable or has cardiogenic shock. 3. Subjects with clinical signs of HF (Kilipp III and IV corresponding to severe HF). 4. Systolic blood pressure 3 x upper limit of normal (ULN), total bilirubin 1.5 ULN, or direct bilirubin >ULN in subjects with Gilbert's syndrome at the Screening Visit. 12. Estimated glomerular filtration rate (eGFR) =4 weeks prior to Screening, or a thyroid-stimulating hormone (TSH) level 1.5 x ULN. 15. History of alcohol or drug abuse within the 3 months prior to the Screening Visit that would interfere with study participation or lead to decreased compliance with study procedures or IP intake in the investigator’s opinion. 16. Participation in another clinical study involving an investigational drug within 30 days prior to Screening, or if a subject plans to participate in another clinical study within 30 days of discontinuation of the IP. 17. Any condition that in the opinion of the investigator would interfere with study participation, may pose a risk to the subject, or would make study participation not in the best interest of the subject. 18. Subjects with a life expectancy of less than 1 year per investigator’s discretion. 19. Any subject who, in the opinion of the investigator, will not be able to follow the protocol. 20. Subjects with an history of documented allergic reactions. 21. Subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the effects of twice daily (bis in die [BID]) oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance imaging (CMRI) on Day 84;Secondary Objective: To compare the effects of BID administration of firibastat and ramipril on: - the change from Baseline to Day 84 in left-ventricle end-diastolic and end-systolic volumes assessed by CMRI - the change from Baseline to Day 84 in average peak of longitudinal and circumferential strain (assessed by CMRI) in the infarcted segments - infarct mass (assessed by CMRI) at Day 84 - major cardiac event (MACE): combined clinical endpoint of cardiovascular death, myocardial infarction (MI), and cardiac hospitalization over 84 days - the change from Baseline to Day 84 in N-terminal pro b-type natriuretic peptide (NT proBNP), procollagen type III aminoterminal peptide (PIIINP), and C reactive protein (CRP) - the slope of decrease in copeptin blood level change between Baseline and Day 84. To compare the safety of firibastat and ramipril;Primary end point(s): Change from Baseline to Day 84 in LVEF assessed by CMRI (centralized reading);Timepoint(s) of evaluation of this end point: Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from Baseline to Day 84 in left-ventricular end-diastolic and end-systolic volumes assessed by CMRI - Change from Baseline to Day 84 in average peak of longitudinal and circumferential strain in the infarcted segments assessed by CMRI - Infarct mass at EOT (Day 84) assessed by CMRI - MACE (i.e., cardiovascular deaths, new MIs, and cardiac hospitalizations) as adjudicated by an independent committee - Change from Baseline in NT-proBNP, PIIINP, and CRP levels to Day 84 - Slope of decrease in copeptin over time;Timepoint(s) of evaluation of this end point: Day 84 | — |
Countries
France, Germany, Hungary, Poland, Russian Federation, Slovakia, Spain, United Kingdom
Contacts
Public ContactMedical Project Manager
Quantum Genomics
Outcome results
None listed