Evidence map›Paper›PMID 36757536›Full record

Trial reportAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2023

Firibastat Versus Ramipril After Acute Mechanical Reperfusion of Anterior Myocardial Infarction: A Phase 2 Study.

Gilles Montalescot, John H Alexander, Angel Cequier-Fillat, Scott D Solomon, Alban Redheuil, Martin Hudec, Johanne Silvain, Nadjia Kachenoura, Adam Janas, Marek Orban and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03715998 (A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction After Acute MI), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.1field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03715998 phase2completednot on this map

A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction After Acute MI

TypeinterventionalSponsorQuantum Genomics SARan2019 to 2021Enrolled295ConditionsMyocardial InfarctionArmsRamipril, Firibastat
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 5 countries.

Gilles MontalescotSorbonne Université, ACTION Group, INSERM UMRS1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), 47-83 Boulevard de l'Hôpital, 75013, Paris, France. gilles.montalescot@aphp.fr.
John H AlexanderDuke Clinical Research Institute, Duke University, Durham, USA.
Angel Cequier-FillatHeart Disease Institute, Bellvitge University Hospital, University of Barcelona, Barcelona, Spain.
Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Alban RedheuilSorbonne Universités, INSERM 1146, CNRS 7371, Laboratoire d'Imagerie Biomédicale, Paris, France.
Martin HudecDepartment of Acute Cardiology, SUSCCH, a.s., Cesta K Nemocnici 1, Banska Bystrica, Slovakia.
Johanne SilvainSorbonne Université, ACTION Group, INSERM UMRS1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), 47-83 Boulevard de l'Hôpital, 75013, Paris, France.
Nadjia KachenouraSorbonne Universités, INSERM 1146, CNRS 7371, Laboratoire d'Imagerie Biomédicale, Paris, France.
Adam Janas10th Department of Interventional Cardiology, Electrophysiology and Electrostimulation, American Heart of Poland, Tychy, Poland.
Marek OrbanDepartment of Acute Cardiology, NÚSCH, a.s., Pod Krásnou hôrkou 1, Bratislava, Slovakia.
Isabelle JosseAixial, CRISCO, Sèvres, France.
Fabrice BalavoineQuantum Genomics, Paris, France.
Bruno BesseQuantum Genomics, Paris, France.
Centre National de la Recherche Scientifique · FRInserm · FRQuantum Genomics (France) · FRAmerican Heart of Poland · PLBellvitge University Hospital · ESBrigham and Women's Hospital · USDuke University · USNational Institute of Cardiovascular Diseases · SK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreclinical data suggest that central renin-angiotensin system blockade by the brain aminopeptidase-A inhibitor firibastat can improve left ventricular ejection fraction (LVEF) after myocardial infarction (MI).

objectivesThis study aimed to compare the effect of firibastat versus ramipril on post-MI LVEF.

methodsIn this phase 2, randomized, double-blind trial, patients selected within 24 h of first acute anterior MI treated by primary percutaneous coronary intervention were randomly assigned (1:1:1) to firibastat 100 mg, firibastat 500 mg or ramipril 5 mg, each twice daily for 12 weeks. The primary endpoint was change in LVEF on cardiac magnetic resonance imaging (cMRI) from baseline to day 84 in the modified intent-to-treat (mITT) population (at least one dose received and one follow-up cMRI available) for each treatment group.

resultsFrom June 4, 2019 to April 12, 2021, 294 patients were randomized and 229 were evaluable for the mITT analysis. After 12 weeks, mean ± standard deviation (SD) percent change in LVEF was 5.6 ± 1.2 with firibastat 100 mg, 5.3 ± 1.1 with firibastat 500 mg and 5.7 ± 1.1 with ramipril. The absolute ± SE adjusted difference in LVEF change from baseline between firibastat 500 mg and ramipril was - 0.36 ± 1.32% (p = 0.79). Occurrence of treatment-related adverse events was similar in the three groups.

conclusionsFiribastat was not superior to ramipril for prevention of left ventricular dysfunction after first acute anterior MI, and their safety profiles were similar. REGISTRATION: ClinicalTrials.gov identifier NCT03715998.

Indexed as

Myocardial InfarctionRamiprilHumansReperfusionStroke VolumeVentricular Function, LeftRamipril

Identifiers

PMID36757536
OpenAlexW4319656347

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.