An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

Trial Profile

An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Rivaroxaban (Primary) ; Aspirin; Clopidogrel; Prasugrel; Ticagrelor; Vitamin K antagonists
  • Indications Thromboembolism
  • Focus Adverse reactions; Registrational
  • Acronyms PIONEER-AF-PCI
  • Sponsors Janssen-Cilag
  • Most Recent Events

    • 21 Aug 2017 According to a Janssen media release, new data from this trial will be presented at the ESC Congress 2017.
    • 21 Jul 2017 According to a Bayer media release, the final decision of the European Commission is expected by the end of this year.
    • 21 Jul 2017 According to a Bayer media release, based on the data from this trial, the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion on a label update regarding the use of 15 mg once daily of Xarelto (Rivaroxaban) in combination with a P2Y12 inhibitor for the treatment of patients with non-valvular atrial fibrillation who require oral anticoagulation and undergo percutaneous coronary intervention with stent placement.
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