Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)

PHASE3TerminatedINTERVENTIONAL
Enrollment

7,213

Participants

Timeline

Start Date

December 23, 2014

Primary Completion Date

February 15, 2018

Study Completion Date

February 15, 2018

Conditions
Stroke
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

15 mg, once daily, orally, tablet

DRUG

Acetylsalicylic acid (Aspirin, BAY1019036)

100 mg, once daily, orally, tablet

OTHER

Rivaroxaban-Placebo

Matching placebo, once daily, orally, tablet

OTHER

Aspirin-Placebo

Matching placebo, once daily, orally, tablet

Trial Locations (454)

1020

Vienna

1070

Bruxelles - Brussel

1078

Buenos Aires

1083

Budapest

1090

Vienna

Brussels

1134

Budapest

1198

Lisbon

1204

Budapest

1205

Geneva

1428

Buenos Aires

1650

San Martín

1700

Fribourg

1828

Banfield

2020

Antwerp

2050

Camperdown

2143

Kistarcsa

2222

Bad Pirawarth

2298

Waratah

2400

Copenhagen

2600

Glostrup Municipality

2650

Edegem

2730

Herlev

3000

Santa Fe

3010

Bern

3011

Footscray

3100

Sankt Pölten

3168

Clayton

3300

Eger

3400

Hillerød

3500

Hasselt

4012

Debrecen

4029

Brisbane

4056

Basel

4100

Durban

4215

Southport

4840

Vöcklabruck

5001

Aarau

5020

Salzburg

5112

Elizabeth Vale

5404

Baden

6009

Nedlands

6100

Ankara

6150

Murdoch

6720

Szeged

6807

Feldkirch

6900

Lugano

7130

Somerset West

7250

Launceston

7531

Cape Town

8000

Aarhus C

8032

Zurich

8310

Bruges

8330

Feldbach

8800

Nagykanizsa

8900

Zalaegerszeg

9002

Győr

9020

Klagenfurt

9100

Aalborg

9200

Dendermonde

9400

Sopron

9500

Villach

10003

Cáceres

10034

Prague

11521

Athens

11528

Athens

12004

Castellon

12200

Berlin

14033

Caen

14080

México, D.F.

14203

Buffalo

15006

A Coruña

15212

Pittsburgh

15706

Santiago de Compostela

16550

Erie

17007

Girona

18014

Granada

19104

Philadelphia

20122

Milan

20127

Aguascalientes

20132

Milan

20162

Milan

20520

Turku

21033

Dijon

21210

Baltimore

22417

Hamburg

24008

León

25198

Lleida

27100

Pavia

28006

Madrid

28007

Madrid

28046

Madrid

29425

Charleston

29609

Brest

30029

Nîmes

30120

El Palmar (Murcia)

30625

Hanover

31000

Antakya

32611

Gainesville

33000

Bordeaux

34098

Istanbul

34100

Trieste

37024

Verona

37126

Verona

40225

Düsseldorf

40536

Lexington

40670

Meerbusch

41009

Seville

41013

Seville

41100

Larissa

41931

Daegu

42075

Konya

42080

Konya

42270

Saint-Priest-en-Jarez

42283

Wuppertal

42415

Daegu

43126

Parma

44035

Nantes

44195

Cleveland

45219

Cincinnati

45500

Ioannina

45750

Sairaalamäki

46000

Kahramanmaraş

46026

Valencia

47011

Valladolid

48013

Bilbao

48043

Mount Clemens

49201

Busan

50009

Zaragoza

58000

Morelia

58633

Jihlava

60126

Ancona

60435

Joliet

61469

Donggu

64460

Monterrey

65130

Vaasa

67091

Strasbourg

67100

L’Aquila

67801

Blansko

68167

Mannheim

70121

New Orleans

75012

Paris

75018

Paris

75390

Dallas

75475

Paris

75634

Paris

75674

Paris

76504

Temple

77030

Houston

78150

Le Chesnay

78229

San Antonio

78701

Austin

79106

Freiburg im Breisgau

81675

München

84312

Salt Lake City

85724

Tucson

86077

Isernia

87042

Limoges

89900

Vibo Valentia

90029

OYS

90502

Torrance

90806

Long Beach

92166

Antony

93053

Regensburg

97070

Mérida

97080

Würzburg

97225

Portland

98102

Seattle

100050

Beijing

100730

Beijing

110016

Shenyang

117997

Moscow

119049

Moscow

130021

Changchun

150000

Yaroslavl

190068

Saint Petersburg

191186

Saint Petersburg

194354

Saint Petersburg

196247

Saint Petersburg

200032

Shanghai

226001

Nantong

248010

Kaluga

264000

Yantai

266003

Qingdao

300000

Tianjin

300052

Tianjin

310009

Hangzhou

317000

Taizhou

325000

Wenzhou

330006

Nanchang

350001

Fuzhou

350005

Fuzhou

400131

Volgograd

410008

Changsha

420012

Kazan'

430014

Wuhan

430034

Wuhan

430060

Wuhan

432063

Ulyanovsk

450052

Zhengzhou

454021

Chelyabinsk

510080

Guangzhou

528000

Foshan

570311

Haikou

603005

Nizhny Novgorod

620017

Yekaterinburg

620102

Yekaterinburg

634063

Tomsk

650032

Kunming

660022

Krasnoyarsk

710038

Xi’an

721008

Baoji

730000

Lanzhou

3339419

Haifa

3436212

Haifa

4941492

Petah Tikva

5262000

Ramat Gan

5506667

Port Montt

6423906

Tel Aviv

7650567

Santiago

7827804

Ashkelon

8410101

Beersheba

8420524

Santiago

94305-5119

Stanford

06520-8064

New Haven

52242-1089

Iowa City

02111

Boston

02118

Boston

01655

Worcester

48109-0330

Ann Arbor

08901

New Brunswick

10016-4576

New York

44106-2602

Cleveland

97239-3011

Portland

29203-8004

Columbia

37232-5400

Nashville

79905-2709

El Paso

C1405CNF

Ciudad Auton. de Buenos Aires

B7602CBM

Mar del Plata

C1039AAO

Buenos Aires

C1221 ADC

Buenos Aires

C1431FWO

Buenos Aires

C1437JCP

Buenos Aires

S2000DSV

Rosario

Unknown

Rosario

Porto Alegre

Los Ángeles

Osorno

Valdivia

Viña del Mar

Viña del Mar

Harbin

Chongqing

Guangzhou

Ostrava Vitkovice

Galway

Jerusalem

México D.F.

Sandomierz

Incheon

Istanbul

C1425DND

Ciudad Auton. de Buenos Aires

X5000JHQ

Córdoba

41253-190

Salvador

30130-100

Belo Horizonte

30150-221

Belo Horizonte

90035-001

Porto Alegre

90110-270

Porto Alegre

89202-165

Joinville

18618 970

Botucatu

13081-000

Campinas

15990-060

Matão

14015-130

Ribeirão Preto

14048-900

Ribeirão Preto

01228-000

São Paulo

08270-070

São Paulo

22281-100

Rio de Janeiro

T2N 2T9

Calgary

T6G 2B7

Edmonton

T6L 5X8

Edmonton

T1K 0C9

Lethbridge

V5Z 1M9

Vancouver

V8R 1J8

Victoria

R7A 2B3

Brandon

E2L 4L2

Saint John

B3H 2Y5

Halifax

L7M 4Y1

Burlington

L8L 2X2

Hamilton

K7L 2V7

Kingston

N6A 5A5

London

N6G 2V4

London

L5B 2V2

Mississauga

K1Y 4E9

Ottawa

P7K 0A4

Thunder Bay

M4N 3M5

Toronto

G7H 5H6

Chicoutimi

H2L 4M1

Montreal

H3G 1A4

Montreal

J7Z 5T3

Saint-Jérôme

G1J 1Z4

Québec

050000

Shijiazhuang

014010

Baotou

625 00

Brno

656 91

Brno

500 05

Hradec Králové

775 20

Olomouc

708 52

Ostrava-Poruba

128 21

Prague

682 01

Vyškov

00029

Helsinki

FIN-53130

Lappeenranta

FIN-33520

Tampere

01129

Dresden

01307

Dresden

04416

Markkleeberg

04779

Wermsdorf

06120

Halle

04600

Altenburg

546 36

Thessaloniki

35-26

Miskolc

H-4400

Nyíregyháza

DUBLIN 7

Dublin

00133

Rome

00152

Rome

00161

Rome

00168

Rome

09134

Cagliari

06012

Perugia

06024

Perugia

06156

Perugia

454-8502

Nagoya

457-8511

Nagoya

460-0001

Nagoya

444-8553

Okazaki

489-8642

Seto

471-8513

Toyota

802-8555

Kitakyushu

805-0050

Kitakyushu

963-8052

Kōriyama

720-0825

Fukuyama

070-8530

Asahikawa

041-0802

Hakodate

085-0061

Kushiro

650-0047

Kobe

652-0803

Kobe

654-0048

Kobe

663-8211

Nishinomiya

259-1193

Isehara

216-8511

Kawasaki

982-8523

Sendai

857-0134

Sasebo

632-8552

Tenri

710-8602

Kurashiki

580-0032

Matsubara

590-0064

Sakai

565-8565

Suita

350-1298

Hidaka

113-8603

Bunkyo-ku

192-0032

Hachiōji

187-8510

Kodaira

180-8610

Musashino

162-8666

Shinjuku-ku

130-8575

Sumida-ku

810-0001

Fukuoka

810-8563

Fukuoka

811-0213

Fukuoka

730-8518

Hiroshima

675-0122

Kakogawa

780-8522

Kochi

600-8558

Kyoto

601-1495

Kyoto

602-8026

Kyoto

950-1197

Niigata

700-8557

Okayama

07760

Gustavo Adolfo Madero

06720

México D.F.

15-276

Bialystok

22-100

Chełm

80-803

Gdansk

80-952

Gdansk

26-200

Gmina Końskie

40-635

Katowice

90-153

Lodz

90-549

Lodz

10-561

Olsztyn

08-110

Siedlce

26-110

Skarżysko-Kamienna

00-146

Warsaw

02957

Warsaw

03-242

Warsaw

4434-502

Vilanova de Gaia

2801-951

Almada

2720-276

Amadora

3030-075

Coimbra

4099-001

Porto

4200-319

Porto

P 2600-178

Vila Franca de Xira

431-070

Anyang-si

411-706

Goyang

463-707

Seongnam-si

152-703

Seoul

05505

Seoul

06351

Seoul

110-744

Seoul

120-752

Seoul

130-872

Seoul

139-872

Seoul

08916

Badalona

08907

L'Hospitalet de Llobregat

08970

Sant Joan Despí

06080

Badajoz

08003

Barcelona

08035

Barcelona

08036

Barcelona

08041

Barcelona

413 45

Gothenburg

281 25

Hässleholm

221 85

Lund

205 02

Malmo

901 85

Umeå

06500

Ankara

HP11 2TT

High Wycombe

MK6 5LD

Milton Keynes

CB2 0QQ

Cambridge

EX2 5DW

Exeter

CO4 5JR

Colchester

SS0 0RY

Westcliff-on-Sea

GL1 3NN

Gloucester

WD1 8HB

Watford

TN24 0LZ

Ashford

CT9 4AN

Margate

LE2 7LX

Leicester

PE21 9QS

Boston

HA1 3UJ

Harrow

NR31 6LA

Great Yarmouth

TA1 5DA

Taunton

BA21 4AT

Yeovil

S10 2JF

Sheffield

ST4 6QG

Stoke-on-Trent

G51 4TF

Glasgow

NE9 6SX

Gateshead

SR4 7TP

Sunderland

WV10 0QP

Wolverhampton

LS1 3EX

Leeds

SP2 8BJ

Salisbury

AB25 2ZN

Aberdeen

DH1 5TW

Durham

EH16 4SA

Edinburgh

N18 1QX

London

SE5 8AF

London

W6 8RP

London

WC1N 3BG

London

LU4 0DZ

Luton

NR4 7UY

Norwich

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

collaborator

Population Health Research Institute

OTHER

lead

Bayer

INDUSTRY