Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Rowlens Melduni, M.D., M.P.H.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

More information

Publications

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

Clinical Trials