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

NCT03715998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2023-02-27

Study results available
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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.

Conditions

Interventions

DRUG

Ramipril

1 or 2 capsules administered orally, twice daily

DRUG

Firibastat

1 or 2 capsules administered orally, twice daily

Sponsors & Collaborators

  • Quantum Genomics SA

    lead INDUSTRY

Principal Investigators

  • Gilles Montalescot, MD, PhD · Groupe Hospitalier Pitié-Salpêtrière - Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-04
Primary Completion
2021-07-08
Completion
2021-07-08

Countries

  • France
  • Germany
  • Hungary
  • Poland
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715998 on ClinicalTrials.gov