Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities

PHASE3CompletedINTERVENTIONAL
Enrollment

6,564

Participants

Timeline

Start Date

August 18, 2015

Primary Completion Date

November 27, 2019

Study Completion Date

January 9, 2020

Conditions
Peripheral Artery Disease
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

2.5 mg, twice daily, orally, tablet

DRUG

Rivaroxaban-Placebo

matching placebo, twice daily, orally, tablet

Trial Locations (532)

300

Hsinchu

704

Tainan City

813

Kaohsiung City

1038

Riga

1070

Bruxelles - Brussel

1078

Buenos Aires

1085

Budapest

1090

Vienna

Bruxelles - Brussel

1106

Budapest

1115

Budapest

1140

Vienna

1160

Vienna

1170

Vienna

1200

Bruxelles - Brussel

1205

Geneva

1309

Sofia

1407

Sofia

1431

Sofia

1601

Kyiv

1606

Sofia

1650

San Martín

1700

Fribourg

1702

Ciudadela

1900

La Plata

2000

Rosario

Samokov

2100

København Ø

2143

Kistarcsa

3000

Leuven

3010

Bern

3400

Corrientes

3526

Miskolc

3600

Genk

3680

Kiev

4002

Plovdiv

4021

Linz

4031

Basel

4032

Debrecen

4400

Nyíregyháza

4500

Panagyurishte

5000

Córdoba

Odense C

5404

Baden

6000

Stara Zagora

Kolding

Lucerne

6020

Innsbruck

6300

Santa Rosa

6725

Szeged

6807

Feldkirch

7000

Chur

7002

Rousse

7013

Rousse

7400

Kaposvár

7600

Mar del Plata

7624

Pécs

8000

Burgas

Székesfehérvár

8036

Graz

8200

Aarhus N

8500

Kortrijk

8600

Yambol

8800

Viborg

9000

Ghent

9007

Sankt Gallen

9010

Varna

9020

Klagenfurt

9023

Győr

9700

Szombathely

10002

Taipei

10011

New York

10029

New York

10100

Prague

10126

Turin

10326

Goyang-si

10330

Bangkok

10400

Bangkok

10700

Bangkok

10713

Berlin

10787

Berlin

11000

Belgrade

11009

Cadiz

11040

Belgrade

11080

Belgrade

11217

Taipei

11312

Tallinn

12808

Prague

12866

Saratoga Springs

13005

Ciudad Real

13419

Tallinn

13620

Seongnam-si

14033

Caen

15006

Prague

A Coruña

15090

São José do Rio Preto

16507

Erie

17011

Camp Hill

17405

York

18000

Niš

18012

Granada

19104

Philadelphia

19140

Philadelphia

20007

Washington D.C.

20132

Milan

20246

Hamburg

20422

Washington D.C.

20735

Clinton

21018

Vinnytsia

21100

Varese

21218

Baltimore

21565

Incheon

23538

Lübeck

27103

Winston-Salem

27259

Kladno

27517

Chapel Hill

27710

Durham

28006

Madrid

28204

Charlotte

28277

Bremen

28630

Le Coudray

29657

Greenville

30599

Pilsen

31008

Pamplona

31300

Toulouse

31403

Toulouse

32117

Daytona Beach

32209

Jacksonville

32216

Jacksonville

32308

Tallahassee

32501

Pensacola

32605

Gainesville

33000

Bordeaux

33075

Bordeaux

33173

Miami

33449

Wellington

33462

Atlantis

33521

Tampere

33604

Bielefeld

33756

Clearwater

34170

Castelnau-le-Lez

34295

Montpellier

34474

Ocala

34667

Hudson

34695

Safety Harbor

35010

Alexander City

35015

Jung-gu Daejeon

35033

Rennes

35144

Panevezys

35967

Fort Payne

37934

Knoxville

38043

Grenoble

38801

Tupelo

39120

Magdeburg

39216

Jackson

40002

Khon Kaen

40138

Bologna

40225

Düsseldorf

40536

Lexington

42100

Reggio Emilia

42472

Daegu

43005

Tarragona

43614

Toledo

45130

Kaunas

45219

Cincinnati

45267

Cincinnati

45414

Dayton

45505

Springfield

46410

Merrillville

46483

Wesel

46804

Fort Wayne

46845

Fort Wayne

47805

Krefeld

48033

Ravenna

48126

Dearborn

48149

Münster

48201

Detroit

48670

Midland

48708

Bay City

48912

Lansing

49000

Dnipro

49201

Busan

49444

Muskegon

49519

Wyoming

50134

Florence

50406

Tartu

50937

Cologne

52242

Iowa City

53713

Madison

54220

Manitowoc

54401

Wausau

55131

Mainz

55433

Coon Rapids

56303

Saint Cloud

57702

Rapid City

58701

Minot

59759

Arnsberg

60005

Arlington Heights

60007

Elk Grove Village

60389

Frankfurt am Main

60596

Frankfurt am Main

61018

Kharkiv

61231

Bad Nauheim

61801

Urbana

62100

Macerata

62701

Springfield

62702

Springfield

63128

St Louis

64276

Darmstadt

65807

Springfield

65929

Frankfurt am Main

67091

Strasbourg

67657

Kaiserslautern

68506

Lincoln

68510

Lincoln

69129

Heidelberg

69501

Hodonín

69600

Zaporizhzhya

70433

Covington

71103

Shreveport

71105

Shreveport

71301

Alexandria

72250

Freudenstadt

73100

Lecce

73135

Oklahoma City

73932

Vratimov

74177

Bad Friedrichshall

75226

Dallas

75634

Paris

75701

Tyler

75908

Paris

76000

Ivano-Frankivsk

76014

Ivano-Frankivsk

76133

Karlsruhe

76307

Karlsbad

77030

Houston

77338

Humble

77339

Kingwood

77340

Huntsville

77901

Victoria

78258

San Antonio

78539

Edinburg

78705

Austin

79010

Lviv

79106

Amarillo

79189

Bad Krozingen

80045

Aurora

80131

Napoli

80220

Denver

80331

München

80336

München

81675

München

82445

Kaohsiung City

83022

Rosenheim

83100

Avellino

83348

Bratislava

85006

Phoenix

85100

Potenza

85340

Glendale

85388

Avondale

86021

Poitiers

87042

Limoges

87509

Immenstadt im Allgäu

89081

Ulm

90110

Songkhla

90127

Palermo

90220

Oulu

90502

Torrance

91054

Erlangen

91325

Northridge

91701

Trnava

92691

Mission Viejo

92901

Dunajská Streda

93053

Regensburg

94304

Palo Alto

94305

Stanford

95661

Roseville

96515

Sonneberg

97100

Ragusa

97123

Hillsboro

100029

Beijing

100053

Beijing

100083

Beijing

100144

Beijing

100730

Beijing

100853

Beijing

105077

Moscow

110084

Piteşti

115682

Moscow

117997

Moscow

129327

Moscow

130021

Changchun

170036

Tver'

191015

Saint Petersburg

194291

Saint Petersburg

194354

Saint Petersburg

195271

Saint Petersburg

197374

Saint Petersburg

200032

Shanghai

200040

Shanghai

210006

Nanjing

213003

Changzhou

230001

Hefei

266003

Qingdao

300000

Tianjin

300736

Timișoara

317000

Taizhou

325000

Wenzhou

333423

Taoyuan District

344022

Rostov-on-Don

350025

Fuzhou

363000

Zhangzhou

390026

Ryazan

394066

Voronezh

400001

Cluj-Napoca

410008

Changsha

410011

Changsha

430014

Wuhan

430030

Wuhan

510080

Guangzhou

510630

Guangzhou

524001

Zhanjiang

528403

Zhongshan

540124

Târgu Mureş

570311

Haikou

603155

Nizhny Novgorod

630055

Novosibirsk

630087

Novosibirsk

634012

Tomsk

650002

Kemerovo

700732

Iași

710038

Xi'an

90619900

Porto Alegre

35294-0012

Birmingham

35801-4317

Huntsville

04240

Lewiston

21201-1595

Baltimore

03756-0001

Lebanon

08822

Flemington

07036

Linden

07666

Teaneck

75216-7167

Dallas

B8001HXM

Bahía Blanca

B7540GHD

Coronel Suárez

B6000BHA

Junín

B1900ASM

La Plata

B1642DCD

San Isidro

C1119ACN

Buenos Aires

C1280AEB

Buenos Aires

C1428ART

Buenos Aires

S2000PBJ

Rosario

S2000QID

Rosario

C1181ACL

Ciudad Auton. de Buenos Aires

X5000AAX

Córdoba

X5006IKK

Córdoba

S3000FWO

Santa Fe

60430 370

Fortaleza

30110-090

Belo Horizonte

30130-100

Belo Horizonte

30140-062

Belo Horizonte

30140-073

Belo Horizonte

38411-186

Uberlândia

80230-130

Curitiba

92200-000

Canoas

99010-080

Passo Fundo

Unknown

Porto Alegre

Chongqing

Guangzhou

Krakow

Oradea

Seoul

Bangkok

30110-130

Belo Horizonte

13060-080

Campinas

09030-010

Santo André

09715-090

São Bernardo do Campo

01323-903

São Paulo

18270-170

Tatuí

20551-030

Rio de Janeiro

R2H 2A6

Winnipeg

A1C 2H6

St. John's

L8L 2X2

Hamilton

ON N6A 5W9

London

K1Y 4E9

Ottawa

G7H 5H6

Chicoutimi

J8Y 6S8

Gatineau

H1T 1C8

Montreal

H1T 2M4

Montreal

H2W 1T8

Montreal

H3T 1E2

Montreal

J7Z 5T3

Saint-Jérôme

H4A 3J1

Montreal, Quebec

G1L 3L5

Québec

V5Z 1M9

Vancouver

030001

Taiyuan

656 91

Brno

500 05

Hradec Králové

460 63

Liberec

775 20

Olomouc

150 06

Prague

798 11

Prostějov

00290

Helsinki

06280

Nice

01099

Dresden

01307

Dresden

04103

Leipzig

07740

Jena

01067

Dresden

00161

Rome

06132

Perugia

480-1195

Nagakute

790-8524

Matsuyama

802-8555

Kitakyushu

805-0050

Kitakyushu

830-8577

Kurume

377-0061

Shibukawa

738-8503

Hatsukaichi

078-8510

Asahikwa

060-0031

Sapporo

064-8622

Sapporo

053-8506

Tomakomai

660-8511

Amagasaki

670-0981

Himeji

671-1227

Himeji

650-0047

Kobe

651-0053

Kobe

665-0873

Takarazuka

020-0066

Morioka

760-8557

Takamatsu

215-0026

Kawasaki

252-5188

Sagamihara

515-8566

Matsusaka

390-8621

Matsumoto

634-8522

Kashihara

874-0011

Beppu

583-0872

Habikino

350-8550

Kawagoe

523-0082

Ōmihachiman

697-8511

Hamada

113-8519

Bunkyo-ku

183-0003

Fuchū

173-0015

Itabashi-ku

173-8610

Itabashi-ku

152-8902

Meguro-ku

108-0073

Minato

108-8329

Minato-ku

166-0001

Suginami-ku

500-8717

Gifu

890-8760

Kagoshima

860-0008

Kumamoto

604-8401

Kyoto

615-8256

Kyoto

880-2102

Miyazaki

530-0012

Osaka

530-8480

Osaka

558-8558

Osaka

336-8522

Saitama

420-8630

Shizuoka

LV-5417

Daugavpils

LV-3414

Liepāja

LV-1002

Riga

LT-50009

Kaunas

LT-08661

Vilnius

LT-10207

Vilnius

5223 GZ

's-Hertogenbosch

5623 EJ

Eindhoven

7611 JH

Enschede

6419 PC

Heerlen

3584 CX

Utrecht

5504 DB

Veldhoven

8025 AB

Zwolle

15_111

Bialystok

85-094

Bydgoszcz

81-338

Gdynia

40-040

Katowice

94-048

Lodz

20-044

Lublin

20-718

Lublin

61-848

Poznan

70-111

Szczecin

01-211

Warsaw

01-868

Warsaw

02-097

Warsaw

50-981

Wroclaw

2805-267

Almada

1169-1024

Lisbon

9500-370

Ponta Delgada

4099-001

Porto

4200-319

Porto

4434-502

Vila Nova de Gaia

010192

Bucharest

011461

Bucharest

022322

Bucharest

085 01

Bardejov

833 48

Bratislava

851 07

Bratislava

04001

Košice

949 01

Nitra

940 01

Nové Zámky

01001

Žilina

700-712

Daegu

301-723

Daejeon

03722

Seoul

05368

Seoul

06351

Seoul

137-701

Seoul

152-703

Seoul

08907

L'Hospitalet de Llobregat

08208

Sabadell

08035

Barcelona

08036

Barcelona

413 46

Gothenburg

582 85

Linköping

205 02

Malmo

171 76

Solna

351 85

Vaxjo

CA2 7HY

Carlisle

HU3 2JZ

Hull

HA1 3UJ

Harrow

DN2 5LT

Doncaster

NE7 7DN

Newcastle upon Tyne

B9 5SS

Birmingham

LS1 3EX

Leeds

WR5 1DD

Worcester

CB3 OLB

Cambridge

GL53 7AN

Cheltenham

NW3 2QG

London

SW17 0QT

London

W6 8RF

London

M13 9WL

Manchester

M23 9LT

Manchester

S5 7AU

Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

collaborator

Colorado Prevention Center

OTHER

lead

Bayer

INDUSTRY