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Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation

Overview

Información sobre este estudio

The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in subjects with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for a maximum of 82 days. Study procedures will include physical examinations, vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood clotting tests, blood samples, urine samples and completion of Quality of Life questionnaires. The study is expected to show that edoxaban will provide comparable incidence rates for efficacy to warfarin plus enoxaparin, the current standard treatment, and will be at least as safe as warfarin for the incidence rate for bleeding

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Signed informed consent
  • Male or female older than minimum legal adult age (country specific)
  • Ongoing AF lasting at least 48 hrs but ≤ 12 months
  • Subject Planned for Electrical Cardioversion

Exclusion Criteria:

  • .AF that is transient or reversible
  • No other rhythm issues other than AF
  • Mitral stenosis or rheumatic disease, unresected atrial myxoma or mechanical heart valve
  • Left atrial appendage closure or thrombus
  • MI, stroke, ACS, PCI within 30 days
  • High risk of bleeding within 10 days or randomization
  • Dual antiplatelet therapy
  • List of prohibited concomitant medication
  • Active liver disease
  • Renal failure, CrCl < 15 ml/min
  • Hemoglobin < 10g/dl or platelet count < 100000 cells/microliter
  • Taking other investigational drugs
  • Women of childbearing potential with proper contraceptives measures
  • Active cancer requiring chemotherapy/radiation/surgery
  • Investigator discretion based on examination

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Rowlens Melduni, M.D., M.P.H.

Cerrado para la inscripción

More information

Publicaciones

  • Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects. The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known. Read More on PubMed

Otros temas en investigación

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CLS-20142982

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