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A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

Trial Profile

A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2023

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At a glance

  • Drugs Flurpiridaz F 18 (Primary)
  • Indications Coronary artery disease
  • Focus Diagnostic use; Registrational
  • Acronyms AURORA
  • Sponsors GE Healthcare
  • Most Recent Events

    • 12 Oct 2023 Results assessing the diagnostic efficacy and safety of flurpiridaz for the detection and evaluation of coronary artery disease (CAD) defined as greater than 50 percent stenosis by quantitative invasive coronary angiography ICA published in the Journal of the American College of Cardiology
    • 28 Aug 2023 Results (n=578) assessing the diagnostic efficacy and safety of flurpiridaz PET for the detection and evaluation of coronary artery disease (CAD) defined as >50% stenosis by quantitative invasive coronary angiography (ICA), presented at the ESC Congress 2023 - Annual Congress of the European Society of Cardiology.
    • 25 Aug 2023 Primary endpoint (Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization) has been met, according to results presented at the ESC Congress 2023 - Annual Congress of the European Society of Cardiology.
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