Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,653

Participants

Timeline

Start Date

December 16, 2015

Primary Completion Date

November 27, 2018

Study Completion Date

November 27, 2018

Conditions
Transcatheter Aortic Valve Replacement
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

10mg OD (once-daily)

DRUG

Acetylsalicylic Acid (ASA)

75-100mg OD

DRUG

Clopidogrel

75mg OD

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

In case of NOAF, 20/15 mg OD (once-daily)

DRUG

Vitamin K antagonist (VKA)

In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines

Trial Locations (140)

1090

Vienna

1130

Vienna

1160

Vienna

3010

Bern

3500

Hasselt

3600

Genk

4000

Liège

4020

Linz

4056

Basel

4600

Wels

5020

Salzburg

6000

Lucerne

6900

Lugano

8036

Graz

8091

Zurich

8200

Aarhus N

9038

Tromsø

10029

New York

10034

Prague

10117

Berlin

11576

Roslyn

12200

Berlin

13353

Berlin

19104

Philadelphia

20010

Washington D.C.

20089

Milan

20132

Milan

20162

Milan

20246

Hamburg

21201

Baltimore

22908

Charlottesville

23795

Bad Segeberg

24105

Kiel

24127

Bergamo

28046

Madrid

28277

Bremen

29010

Málaga

29609

Brest

30322

Atlanta

30625

Hanover

31300

Toulouse

32209

Jacksonville

33011

Oviedo

33136

Miami

33756

Clearwater

35128

Padua

36043

Fulda

36199

Rotenburg A.d. Fulda

37170

Chambray-lès-Tours

39120

Magdeburg

40225

Düsseldorf

41464

Neuss

44137

Dortmund

44195

Cleveland

45219

Cincinnati

47805

Krefeld

48202

Detroit

49100

Angers

50266

West Des Moines

50924

Cologne

52074

Aachen

53105

Bonn

55131

Mainz

55407

Minneapolis

56124

Pisa

59000

Lille

60201

Evanston

60389

Frankfurt am Main

60611

Chicago

61231

Bad Nauheim

64111

Kansas City

66424

Homburg

72076

Tübingen

75014

Paris

75018

Paris

75093

Plano

76508

Temple

77030

Houston

77033

Lahr

78464

Konstanz

79106

Freiburg im Breisgau

80331

München

80636

München

81925

München

89081

Ulm

91054

Erlangen

93042

Regensburg

95124

Catania

97616

Bad Neustadt an der Saale

98405

Tacoma

99437

Bad Berka

90048-0750

Los Angeles

02215

Boston

07962

Morristown

11030-3876

Manhasset

27157-1082

Winston-Salem

18711-3752

Wilkes-Barre

77030-1501

Houston

05401

Burlington

22042-3300

Falls Church

T6G 2B7

Edmonton

V6A 1Y6

Vancouver

V8R 4R2

Victoria

R2H 2A6

Winnipeg

B3H 3A7

Halifax

L3Y 2P7

Newmarket

M4N 3M5

Toronto

M5G 2C4

Toronto

H1T 1C8

Montreal

656 91

Brno

140 21

Prague

DK-2100

Copenhagen

DK-5000

Odense C

04289

Leipzig

1105 AZ

Amsterdam

4818 CK

Breda

3015 CE

Rotterdam

N-5021

Bergen

0424

Oslo

43-316

Bielsko-Biala

02-097

Warsaw

04-628

Warsaw

06351

Seoul

06591

Seoul

110-744

Seoul

120-752

Seoul

08907

L'Hospitalet de Llobregat

08036

Barcelona

751 85

Uppsala

BN2 5BE

Brighton

SO16 6YD

Southampton

FY3 8NR

Blackpool

LE3 9QP

Leicester

BT12 6BA

Belfast

NE7 7DN

Newcastle upon Tyne

LS1 3EX

Leeds

EH16 4SA

Edinburgh

SE1 7EH

London

SE5 9RS

London

OX9 3DU

Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Bayer

INDUSTRY