Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

27,395

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

July 21, 2017

Study Completion Date

June 15, 2021

Conditions
Prevention & Control
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Tablet, 2.5 mg, twice daily, oral

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Tablet, 5 mg, twice daily, oral

DRUG

Aspirin

Tablet, 100 mg, once daily, oral

DRUG

Aspirin placebo

Aspirin matching placebo, once daily, oral

DRUG

Rivaroxaban placebo

Rivaroxaban matching placebo, twice daily, oral

DRUG

Pantoprazole

Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole

DRUG

Pantoprazole placebo

Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo

Trial Locations (565)

0

Quito

9

Dublin

1000

Manila

1070

Bruxelles - Brussel

1085

Budapest

1102

Quezon City

1109

Quezon City

1115

Budapest

1502

Metro Manila

1605

Pasig

1650

San Martín

1780

City of Muntinlupa

1846

Adrogué

1878

Quilmes

1900

La Plata

2000

Rosario

2020

Antwerp

2100

København Ø

2157

Johannesburg

2250

Gosford

2305

New Lambton Heights

2400

Dagupan

2430

Taree

2617

Bruce

2650

Hvidovre

2820

Bonheiden

2900

Hellerup

Laoag

3000

Leuven

3052

Melbourne

3181

Melbourne

Prahran

3220

Geelong

3400

Corrientes

3500

Hasselt

3600

Genk

4000

San Miguel de Tucumán

Liège

4020

Redcliffe

4029

Brisbane

4032

Debrecen

4064

Brisbane

4102

Woolloongabba

4114

Dasmariñas

4300

Holbæk

4575

Birtinya

5000

Iloilo City

5042

Adelaide

5300

Palawan

5400

San Juan

5700

San Luis

6000

Charleroi

Kolding

Cebu City

6009

Nedlands

6014

Port Elizabeth

6150

Murdoch

6300

Santa Rosa

6500

Tacloban City

6850

Worcester

6900

Lugano

7000

Hobart

7100

Szekszárd

7130

Somerset West

7250

Launceston

7405

Pinelands

7503

Pinelands

7531

Cape Town

7624

Pécs

7925

Observatory

8000

Bahía Blanca

Bruges

Székesfehérvár

8200

Aarhus N

8230

Balatonfüred

8500

Kortrijk

8800

Roeselare

Viborg

9200

Mosonmagyaróvár

9300

Bloemfontein

9400

Sopron

10326

Goyang-si

10567

Cortlandt Manor

12351

Berlin

12401

Kingston

12559

Berlin

12866

Saratoga Springs

13353

Berlin

15090

São José do Rio Preto

18901

Doylestown

19047

Langhorne

19067

Yardley

20099

Hamburg

21029

Vinnitsa

21215

Baltimore

25123

Brescia

26100

Cremona

26426

Wŏnju

27100

Pavia

27713

Durham

28374

Pinehurst

30029

Nîmes

32250

Jacksonville Beach

33038

Udine

33057

Udine

33065

Coral Springs

33200

Tampere

33462

Atlantis

33604

Bielefeld

33756

Clearwater

33770

Largo

34059

Montpellier

34128

Kassel

34149

Trieste

34239

Sarasota

34653

New Port Richey

34695

Safety Harbor

35294

Birmingham

36608

Mobile

39120

Magdeburg

40133

Bologna

42117

Wuppertal

42270

Saint-Priest-en-Jarez

43606

Toledo

44035

Elyria

44137

Dortmund

44870

Sandusky

45700

Kuusankoski

46242

Bottrop

47000

Kuala Selangor

Sungai Buloh Selangor

47100

Forlì Cesena

48010

Ravenna

48231

Warendorf

49201

Jackson

49707

Alpena

50053

Florence

50266

West Des Moines

50400

Kuala Lumpur

50659

Bucharest

52044

Arezzo

52803

Davenport

57108

Sioux Falls

59100

Kuala Lumpur

59901

Kalispell

60005

Arlington Heights

60126

Ancona

60429

Hazel Crest

60596

Frankfurt am Main

61002

Kharkiv

61039

Kharkiv

61176

Kharkiv

61348

Bad Homburg

63000

Clermont-Ferrand

63136

St Louis

64239

Tel Aviv

65929

Frankfurt

68100

Batu Caves, Selangor

69118

Zaporizhzhya

70100

Kuopio

71100

Foggia

73042

Lecce

75012

Paris

75018

Paris

75908

Paris

77030

Houston

78229

San Antonio

79044

Lviv

79659

Lviv

80054

Amiens

81027

Caserta

83716

Meridian

86170

Isernia

87042

Limoges

90146

Palermo

90402

Nuremberg

91324

Northridge

91342

Sylmar

92653

Laguna Hills

92801

Anaheim

94901

Nitra

95006

Simferopol

95126

Catania

95494

Santa Rosa

97078

Würzburg

98195

Seattle

98372

Puyallup

99204

Spokane

100029

Beijing

100034

Beijing

100038

Beijing

100088

Beijing

100730

Beijing

101990

Moscow

107084

Moscow

110004

Shenyang

111539

Moscow

117556

Moscow

119435

Moscow

121309

Moscow

127206

Moscow

130000

Changchun

130033

Changchun

140160

Zhukovskiy

200001

Shanghai

200003

Shanghai

200025

Shanghai

200030

Shanghai

200032

Shanghai

200080

Shanghai

210006

Nanjing

210029

Nanjing

230002

Montería

300254

Timișoara

300310

Timișoara

310003

Hangzhou

310016

Hangzhou

325000

Wenzhou

400001

Cluj-Napoca

410011

Changsha

430022

Wudan

500326

Brasov

510080

Guangzhou

510100

Guangzhou

540124

Târgu Mureş

540136

Târgu Mureş

610041

Chengdu

630089

Novosibirsk

634012

Tomsk

650002

Kemerovo

656038

Barnaul

681004

Floridablanca

690767

Jeju City

700503

Iași

700732

Iași

710061

Xi’an

760032

Santiago de Cali

1311001

Safed

1834111

Afula

2170000

Temuco

2210001

Nahariya

2570017

Viña del Mar

3109601

Haifa

3436212

Haifa

4070038

Concepción

4781156

Temuco

4791348

Temuco

5311092

Osorno

5822012

Holon

7500520

Providencia

7500739

Santiago

7830604

Ashkelon

8910108

San Miguel

13060904

Campinas

94304-1207

Palo Alto

90502-2004

Torrance

06851

Norwalk

06905

Stamford

06611

Trumbull

41017-5460

Crestview Hills

01830

Haverhill

08901

New Brunswick

75216-7167

Dallas

77030-4298

Houston

98004-4623

Bellevue

B7540GHD

Coronel Suárez

B6000BHA

Junín

B1902AGY

La Plata

B1902CNF

La Plata

B1902COS

La Plata

B7600FZN

Mar del Plata

B1722COV

Merlo

B1605DSX

Munro

B1740ETD

Ramos Mejía

B2900DMH

San Nicolás de los Arroyos

B1602ABQ

Vicente López

B2800DGH

Zárate

C1119ACN

Buenos Aires

C1428ART

Buenos Aires

C1440AAD

Buenos Aires

C1425AGC

Ciudad Autón. de Buenos Aires

Unknown

Villa Allende

Rosario

Porto Alegre

Votuporanga

Valdivia

Santiago

Wuhan

Beijing

Barranquilla

Manizales

Cartagena

Pasto

Armenia

Pereira

Bucaramanga

Espinal

Barranquilla

Bogotá

Guayaquil

Quito

Ballinasloe

Cork

Galway

Bnei Brak

Tel Aviv

Udine

Batangas

Manila

Portadown

X5900JKA

Villa María

S2300MMA

Rafaela

S2005PAF

Rosario

S2600KUE

Venado Tuerto

T4000IFL

San Miguel de Tucumán

C1023AAB

Ciudad Auton. de Buenos Aires

C1181ACL

Ciudad Auton. de Buenos Aires

C1405BUB

Ciudad Auton. de Buenos Aires

X5000AAW Córdoba

Córdoba

X5000AAX

Córdoba

X5003DCE

Córdoba

X5003DCP

Córdoba

X5004CDT

Córdoba

X5006IKK

Córdoba

A4406CLA

Salta

S3000FWO

Santa Fe

74223 130

Goiânia

30150-240

Belo Horizonte

38025-260

Uberaba

38400-368

Uberlândia

83430 000

Campina Grande do Sul

80730-150

Curitiba

92425-900

Canoas

96015-290

Pelotas

90.620-001

Porto Alegre

90020-090

Porto Alegre

90840-440

Porto Alegre

89010 500

Blumenau

13010-001

Campinas

13020-421

Campinas

15990-060

Matão

15015-750

São José do Rio Preto

01506-001

São Paulo

04012-909

São Paulo

05403-000

São Paulo

T2N 4Z6

Calgary

T6G 2B7

Edmonton

V3L 3W4

New Westminster

V8R 4R2

Victoria

R2H 0R8

Winnipeg

R2H 2A6

Winnipeg

R2V 4W3

Winnipeg

R3T 2E8

Winnipeg

E1G 1A7

Moncton

E2L 4L2

Saint John

B3H 3A7

Halifax

L6W 2X7

Brampton

L7M 4Y1

Burlington

L7R 1E2

Burlington

N1R 6V6

Cambridge

N1R 7R1

Cambridge

P3E 1H5

Greater Sudbury

P3E 6C3

Greater Sudbury

L3M 1P3

Grimsby

L8L 2X2

Hamilton

L8M 1K7

Hamilton

N6A 5A5

London

N6G 2M1

London

L5K 2L3

Mississauga

L3Y 2P6

Newmarket

L3Y 8C3

Newmarket

L6K 3W7

Oakville

L1J 2J9

Oshawa

L1J 2K1

Oshawa

K2H 8T5

Ottawa

K9J 0B2

Peterborough

M1E 5E9

Scarborough Village

M4N 3M5

Toronto

ON N2T 0C1

Waterloo

N8X 5A6

Windsor

G7H 5H6

Chicoutimi

H7M 3L9

Laval

G6V 4Z5

Lévis

H2W 1T8

Montreal

H3G 1A4

Montreal

J1H 5N4

Sherbrooke

J6V 2H2

Terrebonne

G6G 2V4

Thetford-Mines

G8Z 4K4

Trois-Rivières

P3E 5M4

Ontario

G1V 4G5

Québec

625 00

Brno

656 91

Brno

370 01

České Budějovice

381 27

Český Krumlov

695 01

Hodonín

500 05

Hradec Králové

466 60

Jablonec nad Nisou

280 02

Kolín

460 63

Liberec

779 00

Olomouc

708 52

Ostrava

728 80

Ostrava

530 03

Pardubice

100 34

Prague

128 08

Prague

140 21

Prague

150 06

Prague

150 30

Prague

158 00

Prague

169 02

Prague

274 01

Slaný

342 01

Sušice

674 01

Třebíč

739 61

Třinec

686 68

Uherské Hradiště

762 75

Zlín

DK-9000

Aalborg

DK-2400

Copenhagen

FIN-20520

Turku

01600

Vantaa

06280

Nice

01067

Dresden

04289

Leipzig

H-1096

Budapest

H-1125

Budapest

D07 R2WY

Dublin

D08 NHY1

Dublin

06024

Perugia

05100

Terni

453-8511

Nagoya

470-1192

Toyoake

292-8535

Kisarazu

270-2251

Matsudo

794-0006

Imabari

790-0062

Matsuyama

816-0864

Kasuga

802-8555

Kitakyushu

800-0344

Miyako-gun

811-4342

Onga-gun

371-0821

Maebashi

722-8503

Onomichi

070-0038

Asahikawa

070-8610

Asahikawa

006-0852

Sapporo

006-8555

Sapporo

060-0004

Sapporo

053-8567

Tomakomai

654-0026

Kobe

665-0873

Takarazuka

922-8522

Kaga

240-0116

Miura-gun

252-0375

Sagamihara

232-0024

Yokohama

902-8511

Naha

596-0042

Kishiwada

569-1096

Takatsuki

359-1141

Tokorozawa

773-8502

Komatsushimachō

196-0003

Akishima

113-8431

Bunkyo-ku

173-8610

Itabashi-ku

750-0061

Shimonoseki

263-0043

Chiba

812-0033

Fukuoka

814-0180

Fukuoka

500-8384

Gifu

500-8717

Gifu

861-4193

Kumamoto

600-8558

Kyoto

601-1495

Kyoto

615-8256

Kyoto

530-0001

Osaka

530-8480

Osaka

540-0006

Osaka

543-0035

Osaka

558-8558

Osaka

559-0012

Osaka

05460

Kedah

5223 GZ

's-Hertogenbosch

1091 AC

Amsterdam

7334 DZ

Apeldoorn

6815 AD

Arnhem

4818 CK

Breda

2625 AD

Delft

7416 SE

Deventer

7009 BL

Doetinchem

9205 NN

Drachten

6716 RP

Ede

4204 AA

Gorinchem

2803 HH

Gouda

9721 SW

Groningen

6401 CX

Heerlen

5707 HA

Helmond

7909 AA

Hoogeveen

1624 NP

Hoorn

8901 BR

Leeuwarden

7943 KA

Meppel

6532 SZ

Nijmegen

6043 CV

Roermond

4708 AE

Roosendaal

3045 PM

Rotterdam

3083 AN

Rotterdam

8601 ZK

Sneek

4002 WP

Tiel

8011 JW

Zwolle

NCR 1100

Quezon City

80 -126

Gdansk

25-315

Kielce

30-002

Krakow

31-271

Krakow

31-501

Krakow

31-534

Krakow

91-347

Lodz

33-100

Tarnów

53-114

Wroclaw

011461

Bucharest

021659

Bucharest

022322

Bucharest

041915

Bucharest

042122

Bucharest

050098

Bucharest

061114

Bucharest

811 04

Bratislava

813 69

Bratislava

040 22

Košice

080 81

Prešov

952 01

Vráble

463-707

Seongnam-si

150-713

Seoul

614-735

Busan

302-718

Daejeon

03722

Seoul

110-744

Seoul

134-727

Seoul

413 45

Gothenburg

251 87

Helsingborg

291 85

Kristianstad

701 85

Örebro

831 83

Östersund

931 86

Skellefteå

111 35

Stockholm

114 46

Stockholm

141 86

Stockholm

171 76

Stockholm

162 68

Vällingby

49 006

Dnipropetrovsk

02 091

Kiev

02660

Kiev

03 049

Kiev

790 34

Lviv

69 000

Zaporizhzhya

BT16 1RH

Belfast

BT47 6SB

Londonderry Co. Londonderry

SS16 5NL

Basildon

SG1 4AB

Stevenage

FY4 3AD

Blackpool

HA1 3UJ

Harrow

TS4 3BW

Middlesbrough

NN1 5BD

Northampton

TS29 6NH

Hardwick

CV10 7DJ

Nuneaton

B71 4HJ

West Bromich

WV10 0QP

Wolverhampton

WR5 1DD

Worcester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Population Health Research Institute

OTHER

collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY