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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

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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: 15 May 2021

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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

  • 11 May 2021 According to an ARCA biopharma Inc media release, the company continues to evaluate the potential timing for initiation of this trial relative to the COVID-19 pandemic and based on an improving clinical trial ecosystem, has begun organizing necessary trial logistics.
  • 05 Aug 2020 According to an ARCA biopharma Inc media release, initiation of the trial is on hold due to the ongoing COVID-19 pandemic and prioritizing the development of AB201. The company estimates that the trial could start in 2021; however, this estimate is subject to change due to the uncertainties of the ongoing COVID-19 pandemic and the availability of patients for non-COVID-19 related clinical trials.
  • 06 May 2020 Planned initiation date changed from 1 Oct 2019 to 1 Oct 2020. according to an ARCA biopharma Inc media release.

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