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Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF) (ENSURE-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Edoxaban
Warfarin
Enoxaparin
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Nonvalvular atrial fibrillation (NVAF), anti-coagulant, warfarin, edoxaban, electrical cardioversion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has signed informed consent
  • Is older than minimum legal adult age (country specific)
  • Has had ongoing AF lasting at least 48 hrs but <= 12 months (with or without valvular heart disease)
  • Has treatment plan that includes for electrical cardioversion
  • Has NVAF or other specific valvular heart diseases (eg, mitral valve prolapse, mitral valve regurgitation, and aortic valve disease)

Exclusion Criteria:

  • Has AF that is transient or reversible
  • Has contraindicated condition, ie, conditions considered to be formal indication for conventional anticoagulation
  • Has a history of left atrial appendage (LAA) closure
  • Has a known thrombus in LAA, the left atrial, left ventricle or aorta - or an intracardial mass
  • Has had myocardial infarction (MI), stroke, acute coronary syndrome (ACS), or percutaneous coronary intervention (PCI) within the past 30 days
  • Has any contraindication to anticoagulant agents
  • Has had protocol-defined signs of bleeding or conditions associated with high risk of bleeding that would preclude participation
  • Is receiving, or plans to receive during the study period, dual antiplatelet therapy (DAPT) or invasive procedures (other than routine endoscopy) in which bleeding would be anticipated
  • Has received prohibited concomitant medication or therapy
  • Has had protocol-defined signs of bleeding or high
  • Has inadequate liver, kidney, and blood test results
  • Received any investigational drug or device within the past 30 days or plans to during the study period
  • Has reproductive potential and does not agree to take proper contraceptive measures
  • Has active cancer requiring chemotherapy/radiation/major surgery within the next 3 months
  • Has significant active concurrent medical illness or infection or life expectancy less than 6 months
  • In the opinion of the investigator, is unlikely to comply with the protocol or complete the study, has had drug or alcohol dependence within the past year, or has any other condition that might place the participant at increased risk of harm
  • Is a participant in the United States after January 2015 with creatinine clearance (CrCL) greater than 95 mL/minute

Sites / Locations

  • First site in
  • Second site in
  • Bad Friedrichshall
  • First site in
  • Second site in
  • First site in
  • Second site in
  • First site in
  • Second site in
  • First site in
  • Second site in
  • Third site in

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban

Warfarin

Arm Description

Edoxaban oral tablet, 60 mg-once daily (QD), reduced to 30 mg based on protocol-defined parameters, for up to 49 days

Participants naïve to anticoagulation, taking anticoagulants other than a Vitamin K antagonist (VKA) or taking a VKA but with a prothrombin time (PT) international normalized ratio (INR) of less than 2.0 receive enoxaparin until they reach a PT INR of at least 2.0, before taking warfarin. All participants in this arm receive warfarin oral tablet QD at their doctor's prescribed dose, for up to 49 days.

Outcomes

Primary Outcome Measures

Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up
Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding

Secondary Outcome Measures

Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding

Full Information

First Posted
February 20, 2014
Last Updated
March 13, 2019
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02072434
Brief Title
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
Acronym
ENSURE-AF
Official Title
A Prospective, Randomized, Open-Label Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban (DU-176b) With Enoxaparin/Warfarin Followed by Warfarin Alone in Subjects Undergoing Planned Electrical Cardioversion of Nonvalvular Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 25, 2014 (Actual)
Primary Completion Date
February 3, 2016 (Actual)
Study Completion Date
February 3, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.
Detailed Description
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 and urine samples. The study is expected to show that edoxaban will provide comparable incidence rates to warfarin plus enoxaparin, the current standard treatment for both efficacy and bleeding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Nonvalvular atrial fibrillation (NVAF), anti-coagulant, warfarin, edoxaban, electrical cardioversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban
Arm Type
Experimental
Arm Description
Edoxaban oral tablet, 60 mg-once daily (QD), reduced to 30 mg based on protocol-defined parameters, for up to 49 days
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Participants naïve to anticoagulation, taking anticoagulants other than a Vitamin K antagonist (VKA) or taking a VKA but with a prothrombin time (PT) international normalized ratio (INR) of less than 2.0 receive enoxaparin until they reach a PT INR of at least 2.0, before taking warfarin. All participants in this arm receive warfarin oral tablet QD at their doctor's prescribed dose, for up to 49 days.
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Intervention Description
Edoxaban 30 mg tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Warfarin tablet, 1.0 or 2.5 mg, for oral administration
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Enoxaparin per label, at prescribed dose until PT INR at least 2.0
Primary Outcome Measure Information:
Title
Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up
Time Frame
Randomization to end of follow-up (within 2 years)
Title
Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding
Time Frame
During treatment period (within 2 years)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding
Time Frame
From randomization to the end of follow-up (within 2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has signed informed consent Is older than minimum legal adult age (country specific) Has had ongoing AF lasting at least 48 hrs but <= 12 months (with or without valvular heart disease) Has treatment plan that includes for electrical cardioversion Has NVAF or other specific valvular heart diseases (eg, mitral valve prolapse, mitral valve regurgitation, and aortic valve disease) Exclusion Criteria: Has AF that is transient or reversible Has contraindicated condition, ie, conditions considered to be formal indication for conventional anticoagulation Has a history of left atrial appendage (LAA) closure Has a known thrombus in LAA, the left atrial, left ventricle or aorta - or an intracardial mass Has had myocardial infarction (MI), stroke, acute coronary syndrome (ACS), or percutaneous coronary intervention (PCI) within the past 30 days Has any contraindication to anticoagulant agents Has had protocol-defined signs of bleeding or conditions associated with high risk of bleeding that would preclude participation Is receiving, or plans to receive during the study period, dual antiplatelet therapy (DAPT) or invasive procedures (other than routine endoscopy) in which bleeding would be anticipated Has received prohibited concomitant medication or therapy Has had protocol-defined signs of bleeding or high Has inadequate liver, kidney, and blood test results Received any investigational drug or device within the past 30 days or plans to during the study period Has reproductive potential and does not agree to take proper contraceptive measures Has active cancer requiring chemotherapy/radiation/major surgery within the next 3 months Has significant active concurrent medical illness or infection or life expectancy less than 6 months In the opinion of the investigator, is unlikely to comply with the protocol or complete the study, has had drug or alcohol dependence within the past year, or has any other condition that might place the participant at increased risk of harm Is a participant in the United States after January 2015 with creatinine clearance (CrCL) greater than 95 mL/minute
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
City
Phoenix
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Arizona
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United States
City
Escondido
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California
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United States
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Newport Beach
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Riverside
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San Francisco
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Santa Rosa
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Denver
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Stamford
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Newark
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Delaware
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Clearwater
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Daytona Beach
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Jupiter
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Rockledge
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Sarasota
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Tampa
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Boise
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Idaho
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Auburn
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Maine
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Rochester
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Allentown
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Butler
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Camp Hill
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Hershey
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Jackson
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Dallas
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Fort Worth
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Plano
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Tyler
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Richmond
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Virginia
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Modling
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Austria
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Wien
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Austria
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Brussels
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Huy
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Mechelen
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Belgium
City
Tienen
Country
Belgium
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Turnhout
Country
Belgium
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Burgas
Country
Bulgaria
City
Gabrovo
Country
Bulgaria
City
Pazardzhik
Country
Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
Country
Bulgaria
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Stara Zagora
Country
Bulgaria
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Varna
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Bulgaria
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Veliko Tarnovo
Country
Bulgaria
City
Brno
Country
Czechia
City
Cesky Krumlov
Country
Czechia
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Havlickuv Brod
Country
Czechia
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Hodonin
Country
Czechia
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Kolin
Country
Czechia
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Kromeriz
Country
Czechia
City
Nachod
Country
Czechia
City
Praha 4
Country
Czechia
City
Praha 6
Country
Czechia
City
Pribram
Country
Czechia
City
Slany
Country
Czechia
City
Aalborg
Country
Denmark
Facility Name
First site in
City
Copenhagen
Country
Denmark
Facility Name
Second site in
City
Copenhagen
Country
Denmark
City
Frederiksberg
Country
Denmark
City
Hellerup
Country
Denmark
City
Herning
Country
Denmark
City
Holbaek
Country
Denmark
City
Køge
Country
Denmark
City
Silkeborg
Country
Denmark
City
Slagelse
Country
Denmark
City
Svendborg
Country
Denmark
City
Vejle
Country
Denmark
City
Viborg
Country
Denmark
City
Angers cedex 9
Country
France
City
Bordeaux
Country
France
City
Bron cedex
Country
France
City
Corbeil Essonnes
Country
France
City
Dijon cedex
Country
France
City
Grenoble cedex 09
Country
France
City
Lyon
Country
France
City
Marseille cedex 20
Country
France
City
Marseille cedex 5
Country
France
City
Montfermeil
Country
France
City
Montpellier Cedex 5
Country
France
City
Nice
Country
France
City
Paris
Country
France
City
Saint-Denis cedex
Country
France
City
Toulouse cedex 9
Country
France
City
Vandoeuvre les Nancy cedex
Country
France
City
Bad Berka
Country
Germany
City
Berlin
Country
Germany
City
Bielefeld
Country
Germany
City
Coburg
Country
Germany
City
Dortmund
Country
Germany
City
Dresden
Country
Germany
City
Freiburg
Country
Germany
City
Giessen
Country
Germany
City
Hamburg
Country
Germany
City
Heidelberg
Country
Germany
Facility Name
Bad Friedrichshall
City
Heilbronn
Country
Germany
City
Langen
Country
Germany
City
Leipzig
Country
Germany
City
Ludwigsburg
Country
Germany
City
Mainz
Country
Germany
City
Marburg
Country
Germany
City
Monchengladbach
Country
Germany
City
Munchen
Country
Germany
City
Paderborn
Country
Germany
City
Regensburg
Country
Germany
City
Balatonfured
Country
Hungary
Facility Name
First site in
City
Budapest
Country
Hungary
Facility Name
Second site in
City
Budapest
Country
Hungary
City
Cegled
Country
Hungary
City
Debrecen
Country
Hungary
City
Gyula
Country
Hungary
City
Győr
Country
Hungary
City
Hodmezovasarhely
Country
Hungary
City
Kecskemet
Country
Hungary
City
Nagykanizsa
Country
Hungary
City
Pécs
Country
Hungary
City
Szeged
Country
Hungary
City
Szekesfehervar
Country
Hungary
City
Szolnok
Country
Hungary
City
Szombathely
Country
Hungary
City
Zalaegerszeg
Country
Hungary
City
Afula
Country
Israel
City
Ashkelon
Country
Israel
City
Hadera
Country
Israel
City
Haifa
Country
Israel
City
Holon
Country
Israel
City
Jerusalem
Country
Israel
City
Kfar Saba
Country
Israel
City
Ramat Gan
Country
Israel
City
Tel Aviv
Country
Israel
City
Acquaviva delle Fonti
State/Province
BA
Country
Italy
City
Santa Maria Capua Vetere
State/Province
CE
Country
Italy
City
Mestre
State/Province
VE
Country
Italy
City
Bologna
Country
Italy
City
Catania
Country
Italy
City
Chieti
Country
Italy
City
Napoli
Country
Italy
City
Pavia
Country
Italy
Facility Name
First site in
City
Roma
Country
Italy
Facility Name
Second site in
City
Roma
Country
Italy
City
Trieste
Country
Italy
City
Amsterdam
Country
Netherlands
City
Den Haag
Country
Netherlands
City
Hilversum
Country
Netherlands
City
Leeuwarden
Country
Netherlands
City
Rotterdam
Country
Netherlands
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Venlo
Country
Netherlands
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Zwolle
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Netherlands
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Elblag
Country
Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Pulawy
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Wroclaw
Country
Poland
City
Oradea
State/Province
Bihor
Country
Romania
City
Craiova
State/Province
Dolj
Country
Romania
City
Focsani
State/Province
Vrancea
Country
Romania
City
Baia Mare
Country
Romania
City
Braila
Country
Romania
City
Bucuresti
Country
Romania
City
Cluj-Napoca
Country
Romania
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Iasi
Country
Romania
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Pitesti
Country
Romania
City
Targoviste
Country
Romania
City
Timisoara
Country
Romania
City
Târgu-Mureş
Country
Romania
City
Barnaul
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Saint-Petersburg
Country
Russian Federation
City
Tyumen
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
San Juan de Alicante
State/Province
Alicante
Country
Spain
City
Sabadell
State/Province
Barcelona
Country
Spain
City
Salt
State/Province
Girona
Country
Spain
City
Almeria
Country
Spain
Facility Name
First site in
City
Barcelona
Country
Spain
Facility Name
Second site in
City
Barcelona
Country
Spain
City
Granada
Country
Spain
City
Lugo
Country
Spain
Facility Name
First site in
City
Madrid
Country
Spain
Facility Name
Second site in
City
Madrid
Country
Spain
Facility Name
Third site in
City
Madrid
Country
Spain
City
Ourense
Country
Spain
City
Santiago de Compostela
Country
Spain
City
Valencia
Country
Spain
City
Vigo
Country
Spain
City
Helsingborg
Country
Sweden
City
Uppsala
Country
Sweden
City
Cherkasy
Country
Ukraine
City
Ivano-Frankivsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Odesa
Country
Ukraine
City
Uzhhorod
Country
Ukraine
City
Vinnytsia
Country
Ukraine
City
Zaporizhzhia
Country
Ukraine
City
Zhytomyr
Country
Ukraine
City
Romford
State/Province
Essex
Country
United Kingdom
City
Southampton
State/Province
Hampshire
Country
United Kingdom
City
Blackpool
State/Province
Lancashire
Country
United Kingdom
City
Barnet
Country
United Kingdom
City
Basildon
Country
United Kingdom
City
Birmingham
Country
United Kingdom
City
Bournemouth
Country
United Kingdom
City
Bradford
Country
United Kingdom
City
Chertsey
Country
United Kingdom
City
Doncaster
Country
United Kingdom
City
Dundee
Country
United Kingdom
City
Harrow
Country
United Kingdom
City
Leeds
Country
United Kingdom
City
Leicester
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
Llanelli
Country
United Kingdom
City
London
Country
United Kingdom
City
Luton
Country
United Kingdom
City
Newport
Country
United Kingdom
City
Oxford
Country
United Kingdom
City
Plymouth
Country
United Kingdom
City
Swansea
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
24251359
Citation
Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
Results Reference
background
PubMed Identifier
29947751
Citation
Goette A, Kwong WJ, Ezekowitz MD, Banach M, Hjortshoj SP, Zamoryakhin D, Lip GYH. Edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources: an analysis from the EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of atrial fibrillation (ENSURE-AF) study. Europace. 2018 Dec 1;20(12):1936-1943. doi: 10.1093/europace/euy141.
Results Reference
derived
PubMed Identifier
27590218
Citation
Goette A, Merino JL, Ezekowitz MD, Zamoryakhin D, Melino M, Jin J, Mercuri MF, Grosso MA, Fernandez V, Al-Saady N, Pelekh N, Merkely B, Zenin S, Kushnir M, Spinar J, Batushkin V, de Groot JR, Lip GY; ENSURE-AF investigators. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016 Oct 22;388(10055):1995-2003. doi: 10.1016/S0140-6736(16)31474-X. Epub 2016 Aug 30. Erratum In: Lancet. 2016 Oct 22;388(10055):1984.
Results Reference
derived
PubMed Identifier
25965706
Citation
Lip GY, Merino J, Ezekowitz M, Ellenbogen K, Zamoryakhin D, Lanz H, Jin J, Al-Saadi N, Mercuri M, Goette A. A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: The EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation (ENSURE-AF) study. Am Heart J. 2015 May;169(5):597-604.e5. doi: 10.1016/j.ahj.2015.02.009. Epub 2015 Feb 21.
Results Reference
derived

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Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)

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