Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

PHASE3CompletedINTERVENTIONAL
Enrollment

1,504

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Atrial Fibrillation
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 20 mg orally once daily; subjects with moderate renal impairment (ie, CrCl of 30 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily in the study

DRUG

Vitamin K antagonist (VKA)

VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards

Trial Locations (178)

1070

Bruxelles - Brussel

1449

Alberton

2013

Soweto

2400

Mol

København NV

2900

Hellerup

3000

Leuven

3500

Hasselt

4000

Liège

6060

Gilly

6850

Worcester

7130

Somerset West

7400

Herning

7450

Cape Town

7505

Cape Town

7580

Kuils River

8800

Viborg

9301

Bloemfontein

10013

New York

10032

New York

10126

Torino

11526

Attica / Athens

12180

Troy

13353

Berlin

14215

Buffalo

15009

Beaver

16001

Butler

17033

Hershey

18012

Granada

18901

Doylestown

19102

Philadelphia

19141

Philadelphia

19803

Wilmington

20097

San Donato Milanese

20246

Hamburg

20521

Turku

20853

Rockville

21044

Columbia

21401

Annapolis

22020

San Fermo della Battaglia

28007

Madrid

28222

Majadahonda

28500

Pori

28805

Asheville

30174

Mestre

31008

Pamplona

31059

Toulouse

31419

Savannah

32117

Daytona Beach

32216

Jacksonville

Saint Augustine

32308

Tallahassee

32545

Bad Oeynhausen

32725

Deltona

32806

Orlando

32901

Melbourne

33021

Hollywood

33135

Miami

33308

Fort Lauderdale

33316

Fort Lauderdale

33604

Pessac

33756

Clearwater

33805

Lakeland

36608

Mobile

37044

Tours

37203

Nashville

37232

Nashville

37604

Johnson City

40620

Jyväskylä

41063

Mönchengladbach

43623

Toledo

44195

Cleveland

44708

Cantan

44906

Mansfield

45147

Essen

54401

Wausau

54500

Vandœuvre-lès-Nancy

54642

Thessaloniki

55131

Mainz

57701

Rapid City

59037

Lille

60007

Elk Grove Village

60126

Ancona

60435

Joliet

60504

Aurora

60596

Frankfurt am Main

60612

Chicago

60637

Chicago

61107

Rockford

62000

Arras

65130

Vaasa

68100

Alexandroupoli

68516

Lincoln

70021

Acquaviva delle Fonti

75012

Paris

75013

Paris

75018

Paris

75231

Dallas

75701

Tyler

78745

Austin

79106

Freiburg im Breisgau

84041

Layton

85258

Scottsdale

87102

Albuquerque

89086

North Las Vegas

90471

Nuremberg

91950

National City

92020

El Cajon

94303

East Palo Alto

95126

Catania

95494

Santa Rosa

95819

Sacramento

96101

Rovaniemi

98166

Burien

98225

Bellingham

100029

Beijing

119228

Singapore

168752

Singapore

200080

Shanghai

308433

Singapore

330006

Nanchang

410011

Changsha

510080

Guangzhou

710061

Xi'an

768828

Singapore

13060904

Campinas

90502-2004

Torrance

06520

New Haven

06905

Stamford

08807

Bridgewater

07716

Manalapan

78234-6200

Fort Sam Houston

80730-150

Curitiba

90610-000

Porto Alegre

13010-001

Campinas

05403-900

São Paulo

T5H 3V9

Edmonton

V8R 4R2

Victoria

E2L 4L2

Saint John

A1B 3V6

St. John's

L8L 2X2

Hamilton

M5B 1W8

Toronto

H1T 1C8

Montreal

H2W 1T8

Montreal

G1V 4G5

Québec

Unknown

Wuhan

Changchun

Ürümqi

Shenyang

Lappeenranta

Oulu

FIN-00260

Helsinki

FIN-33520

Tampere

01067

Dresden

04289

Leipzig

711 10

Heraklion

00169

Roma

6815 AD

Arnhem

2035 RC

Haarlem

6419 PC

Heerlen

8934 AD

Leeuwarden

6229 HX

Maastricht

3041-801

Martinho Do Bispo

8000-386

Faro

2795-53

Carnaxide

2801-951

Almada

1169-024

Lisbon

4434-502

Vila Nova de Gaia

08036

Barcelona

08208

Sabadell

S44 5BL

Chesterfield

BH7 7DW

Bournemouth

AL7 4HQ

Welwyn Garden City

LE3 9QP

Leicester

NG5 1PB

Nottingham

NN1 5BD

Cliftonville

SW17 0RE

London

PO6 3LY

Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY

NCT01674647 - Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion | Biotech Hunter | Biotech Hunter