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A double-blind, active-controlled, multicenter, international Phase 3 clinical trial comparing Gencaro with Toprol-XL (metoprolol succinate) for the prevention of recurrent AF or all-cause mortality (ACM) in HFrEF patients

Trial Profile

A double-blind, active-controlled, multicenter, international Phase 3 clinical trial comparing Gencaro with Toprol-XL (metoprolol succinate) for the prevention of recurrent AF or all-cause mortality (ACM) in HFrEF patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2019

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At a glance

  • Drugs Bucindolol (Primary) ; Metoprolol succinate
  • Indications Atrial fibrillation; Heart failure
  • Focus Registrational; Therapeutic Use
  • Acronyms PRECISION-AF
  • Sponsors ARCA biopharma Inc
  • Most Recent Events

    • 01 Aug 2019 According to an ARCA biopharma media release, the company anticipates to initiate this study the first quarter of 2020.
    • 01 Aug 2019 According to an ARCA biopharma media release, in July 2019, the U.S. Food and Drug Administration (FDA) agreed to amend the Special Protocol Assessment (SPA) agreement for the Phase 3 PRECISION-AF clinical trial to expand the target trial population to include heart failure patients with left ventricular injection fractions (LVEF) > 40% and < 55%.
    • 23 Apr 2019 According to an ARCA biopharma media release, subject to securing additional financing, ARCA anticipates initiating this study in the fourth quarter of 2019.
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