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QUORUM

To compare the effects of firibastat to those of ramipril to prevent left ventricular dysfunction after acute myocardial infarction

En cours

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objectif

To compare the effects of twice daily oral administration of firibastat to those of oral administration of ramipril on the change from Baseline in left ventricular ejection fraction after an acute anterior myocardial infarction.

date de réalisation

2019

nombre de patients

294

nombre de centres participants

International multicentric trial

type de financement

Private (Quantum Genomics)

Référence

NCT03715998

Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction (QUORUM)

Study Description

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:

  • Group 1: Subjects will receive 50 mg firibastat BID for 2 weeks and then 100 mg BID for 10 weeks
  • Group 2: Subjects will receive 250 mg firibastat BID for 2 weeks and then 500 mg BID for 10 weeks
  • Group 3: Subjects will receive 2.5 mg ramipril BID for 2 weeks and then 5 mg BID for 10 weeks

source clinicaltrials.gov

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