Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction
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.
Timeline
- Start
- 2019-06-04
- Primary completion
- 2021-07-08
- Completion
- 2021-07-08
Outcome
Missed primary endpoint
paper The absolute ± SE adjusted difference in LVEF change from baseline between firibastat 500 mg and ramipril was - 0.36 ± 1.32% (p = 0.79). PMID 36757536 ↗
paper Firibastat was not superior to ramipril for prevention of left ventricular dysfunction after first acute anterior MI PMID 36757536 ↗
Publications
- Montalescot G, Alexander JH, Cequier-Fillat A, Solomon SD, Redheuil A, Hudec M, Silvain J, Kachenoura N, Janas A, Orban M, Josse I, Balavoine F, Besse B. Firibastat Versus Ramipril After Acute Mechanical Reperfusion of Anterior Myocardial Infarction: A Phase 2 Study. Am J Cardiovasc Drugs. 2023 Mar;23(2):207-217. doi: 10.1007/s40256-023-00567-8. Epub 2023 Feb 9.
- Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Firibastat | Small molecule | 100 mg | Oral |
| Subject | Firibastat | Small molecule | 500 mg | Oral |
| Comparator | Ramipril | Small molecule | 5 mg | Oral |