Phase 2
Completed N=295
Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction
Source: ClinicalTrials.gov NCT03715998 ↗Enrolled (actual)
295
Serious AEs
13.3%
Results posted
Feb 2023
Primary outcomePrimary: Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI) — 5.6; 5.3; 5.7 percentage of left ventricular volumes
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Ejection Fraction Assessed by Cardiac Magnetic Resonance Imaging (CMRI) |
5.6; 5.3; 5.7 | — |
| SECONDARY Left-ventricle End-diastolic Volume Assessed by CMRI |
14.2; 12.7; 9.4 | — |
| SECONDARY Left-ventricle End-systolic Volume Assessed by CMRI |
-0.5; -0.4; -3.1 | — |
| SECONDARY Major Cardiac Event (MACE): Combined Clinical Endpoint of Cardiovascular Death, MI, and Cardiac Hospitalization |
10; 8; 6 | — |
| SECONDARY N-terminal Pro B-type Natriuretic Peptide (NT proBNP) |
-1618.7; -1596.4; -1735.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
- Primary PCI of the index-MI-related artery within 24 hours after the MI.
Exclusion Criteria
- Body mass index >45 kg/m².
- Subject is hemodynamically unstable or has cardiogenic shock.
- Subjects with clinical signs of HF (Kilipp III and IV).
- Systolic blood pressure <100 mmHg at inclusion visit
- Early primary PCI of the index-MI-related artery performed within 3 hours after MI.
- Subjects treated with angiotensin-converting-enzyme inhibitor (ACE I), angiotensin receptor blocker (ARB) or sacubitril/valsartan prior to the index magnetic resonance imaging. Note: if treatment was for HTN, ACE I/ARB should be stopped, and, if necessary, another therapeutic class can be prescribed for HTN. If the ACE I/ARB was prescribed for congestive HF, the subject is not considered eligible; if the ACE I/ARB prescribed for another reason cannot be stopped, the subject is not eligible for study inclusion.
- Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy, or pacemaker within the next 3 months. If an ICD is indicated for ventricular arrhythmia during the course of the study, a life vest, when possible, should be prescribed and the ICD scheduled after study completion.
Data sourced from ClinicalTrials.gov (NCT03715998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.