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objectif
Étude de phase II, multicentrique, randomisée, prospective, en double aveugle comparant le traitement de référence (Ramipril) versus nouveau traitement (Firibastat) chez des patients ayant eu un infarctus du myocarde antérieur.
date de réalisation
2019
nombre de patients
294
nombre de centres participants
Étude internationale multicentrique
type de financement
Privé (Quantum Genomics)
Référence
NCT03715998
Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction (QUORUM)
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:
source clinicaltrials.gov
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