Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study

PHASE3CompletedINTERVENTIONAL
Enrollment

4,833

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

September 30, 2011

Study Completion Date

December 31, 2011

Conditions
Pulmonary Embolism
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.

DRUG

Enoxaparin overlapping with and followed by VKA

Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.

Trial Locations (305)

112

Taipei

220

Taipei

1005

Lausanne

1011

Lausanne

1023

Auckland

1070

Bruxelles - Brussel

1090

Vienna

1096

Budapest

1102

Quezon City

1115

Budapest

1140

Vienna

1171

Vienna

1200

Bruxelles - Brussel

1211

Genéve 14

1309

Rud

1603

Fredrikstad

1724

Roodepoort

2024

Auckland

2031

Sydney

2065

St Leonards

2132

Johannesburg

2139

Sydney

2143

Kistarcsa

2157

Johannesburg

2191

Johannesburg

2217

Kogarah

2229

Sydney

2250

Gosford

2480

Lismore

2500

Lier

2570

Duffel

2605

Garran

3000

Leuven

3010

Bern

3128

Box Hill

3135

Melbourne

3168

Clayton

3181

Melbourne

3220

Geelong

3500

Hasselt

3526

Miskolc

3600

Genk

4000

Liège

4010

Linz

4020

Redcliffe

4029

Brisbane

4032

Debrecen

4102

Woolloongabba

4215

Southport

4414

Palmerston North

5000

Namur

5011

Woodville South

5042

Adelaide

5530

Yvoir

6000

Perth

Kecskemét

Lucerne

6020

Innsbruck

6021

Wellington South

6160

Fremantle

6600

Szentes

6807

Feldkirch

6850

Worcester

7000

Chur

7006

Trondheim

7100

Szekszárd

7130

Somerset West

7250

Launceston

7460

Cape Town

8000

Aarhus C

8011

Christchurch

8036

Graz

8091

Zurich

8740

Brædstrup

8900

Zalaegerszeg

9000

Ghent

9300

Aalst

9620

Zottegem

9700

Szombathely

10016

Taipei

10138

Tallinn

10330

Jakarta

Pathumwan, Bangkok

10400

Bangkok

10430

Jakarta

12099

Berlin

12800

Prague

13100

Safed

15224

Pittsburgh

17007

Girona

17011

Camp Hill

17475

Greifswald

18101

Afula

20089

Rozzano

20122

Milan

20132

Milan

20142

Milan

20152

Medan

20251

Hamburg

20520

Turku

21000

Dijon

21100

Varese

21215

Baltimore

22401

Fredericksburg

25000

Besançon

27100

Pavia

27200

Vernon

27259

Kladno

27342

Rotenburg (Wümme)

27401

Greensboro

27403

Greensboro

28034

Madrid

29100

Piacenza

29609

Brest

30122

Venezia

31008

Pamplona

31048

Haifa

31096

Haifa

31403

Toulouse

33000

Bordeaux

33098

Paderborn

33136

Miami

33521

Tampere

33744

Bay Pines

34170

Castelnau-le-Lez

34295

Montpellier

34362

Haifa

35128

Padua

38043

Grenoble

39112

Magdeburg

40138

Bologna

40161

Bandung

40705

Taichung

42055

Saint-Etienne

42100

Reggio Emilia

42328

Roanne

43100

Parma

44000

Nantes

44281

Kfar Saba

45122

Essen

46242

Bottrop

46340

Requena

47010

Valladolid

47923

Agen

49033

Angers

49100

Petah Tikva

50200

Chiang Mai

50241

Semarang

54511

Vandœuvre-lès-Nancy

55131

Mainz

58100

Holon

58455

Witten

59322

Valenciennes

60590

Frankfurt am Main

60596

Frankfurt am Main

62000

Arras

63000

Clermont-Ferrand

63017

Chesterfield

64239

Tel Aviv

64297

Darmstadt

64300

Orthez

66013

Chieti

67091

Strasbourg

68000

Kuala Selangor

69115

Heidelberg

69120

Heidelberg

69151

Neckargemünd

69495

Pierre-Bénite

70433

Covington

72076

Tübingen

72205

Little Rock

73104

Oklahoma City

74370

Metz-Tessy

75004

Paris

75015

Paris

75475

Paris

75877

Paris

75908

Paris

76031

Rouen

76100

Rehovot

76307

Karlsbad

76646

Bruchsal

78229

San Antonio

78278

Ashkelon

80000

Amiens

80331

München

81377

München

83000

Toulon

83404

Idaho Falls

84107

Murray

84132

Salt Lake City

86156

Augsburg

87042

Limoges

87108

Albuquerque

90127

Palermo

91120

Jerusalem

92141

Clamart

92373

Redlands

92701

Colombes

97080

Würzburg

98405

Tacoma

99204

Spokane

99734

Nordhausen

100020

Beijing

100029

Beijing

100037

Beijing

100038

Beijing

100044

Beijing

100730

Beijing

100853

Beijing

110016

Shenyang

110060

New Delhi

150086

Harbin

169608

Singapore

200001

Shanghai

200032

Shanghai

200433

Shanghai

215004

Suzhou

308433

Singapore

310016

Hangzhou

411001

Pune

430022

Wuhan

500082

Hyderabad

510080

Guangzhou

510120

Guangzhou

530021

Nanning

682026

Kochi

86038440

Londrina

33136-1096

Miami

02215

Boston

27599-7035

Chapel Hill

Unknown

Les Escaldes

Rio de Janeiro

Guangzhou

Hong Kong

Wan Chai

Ballinasloe

London

80050-350

Curitiba

18618 000

Botucatu

01323-001

São Paulo

01509-900

São Paulo

04039-004

São Paulo

08270-070

São Paulo

18031-000

Sorocaba

R2H 2A6

Winnipeg

N6A 4G5

London

K1Y 4E9

Ottawa

M4N 3M5

Toronto

M6R 1B5

Toronto

728 80

Ostrava

708 52

Ostrava-Poruba

110 00

Prague

150 00

Prague

269 01

Rakovník

401 13

Usti Nad Lebem

2000F

Frederiksberg

06002

Nice

01307

Dresden

06120

Halle

LV 3414

Liepāja

LT-50009

Kaunas

LT-08661

Vilnius

1105 AZ

Amsterdam

6815 AD

Arnhem

7511 JX

Enschede

9713 GZ

Groningen

2134 TM

Hoofddorp

6229 HX

Maastricht

8025 AB

Zwolle

0622

Auckland

0407

Oslo

0850

Quezon City

15-276

Bialystok

31-066

Krakow

90-153

Lodz

20-081

Lublin

60-631

Poznan

61-848

Poznan

87-100

Torun

01-138

Warsaw

50-326

Wroclaw

51-124

Wroclaw

00927

San Juan

0084

Pretoria

0157

Pretoria

0181

Pretoria

110-744

Seoul

705-718

Daegu

120-752

Seoul

700-712

Taegu

08025

Barcelona

08036

Barcelona

08221

Terrassa

07010

Palma de Mallorca

501 82

Borås

413 45

Gothenburg

416 85

Gothenburg

551 85

Jönköping

118 83

Stockholm

851 86

Sundsvall

PL6 8DH

Plymouth

TW7 6AF

Isleworth

SE1 7EH

London

SE5 9RS

London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

lead

Bayer

INDUSTRY