Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

PHASE3CompletedINTERVENTIONAL
Enrollment

1,280

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

January 31, 2010

Conditions
Atrial Fibrillation
Interventions
DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Participants orally administered rivaroxaban 15 mg OD (CrCL \[creatinine clearance\] \>= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min)

DRUG

Warfarin

Participants orally administered a warfarin potassium tablet (INR \[international normalized ratio\] target was 1.6-2.6 for patients \>70 years and 2.0-3.0 for patients \<70 years)

DRUG

Rivaroxaban placebo

Participants orally administered a rivaroxaban placebo tablet

DRUG

Warfarin placebo

Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)

Trial Locations (165)

487-0013

Kasugai

453-8511

Nagoya

454-8502

Nagoya

455-8530

Nagoya

457-8510

Nagoya

462-0825

Nagoya

444-8553

Okazaki

037-0053

Goshogawara

036-8082

Hirosaki

036-8545

Hirosaki

289-2511

Asahi

274-8503

Funabashi

270-1694

Imba

270-2251

Matsudo

271-0077

Matsudo

284-0032

Yotsukaidō

799-1592

Imabari

790-0024

Matsuyama

790-0925

Matsuyama

791-8026

Matsuyama

792-8543

Niihama

793-0030

Saijō

791-0281

Tōon

910-0067

Fukui-shi

811-1244

Chikushi-gun

818-8502

Chikushino-shi

818-8516

Chikushino-shi

810-8563

Fukuoka

811-0213

Fukuoka

813-0044

Fukuoka

814-0180

Fukuoka

816-0833

Kasuga

816-0864

Kasuga

800-0057

Kitakyushu

806-8501

Kitakyushu

830-8577

Kurume

838-0141

Ogōri

834-0004

Yame

834-0006

Yame

963-8052

Kōriyama

500-8225

Gifu

503-8502

Ōgaki

371-8511

Maebashi

371-0014

Mebashi

739-0696

Ōtake

078-8214

Asahikawa

066-0034

Chitose

040-8611

Hakodate

051-8501

Muroran

047-8510

Otaru

004-0052

Sapporo

060-0033

Sapporo

060-0061

Sapporo

060-8570

Sapporo

064-0807

Sapporo

064-8570

Sapporo

065-0027

Sapporo

065-0033

Sapporo

065-8611

Sapporo

073-0196

Sunagawa

053-8506

Tomakomai

651-0073

Kobe

651-1145

Kobe

652-0803

Kobe

311-3193

Higashiibaraki

317-0077

Hitachi

303-0016

Jōsō

309-1793

Kasama

302-0112

Moriya

311-3516

Namegata

302-0022

Toride

920-8650

Kanazawa

923-1100

Nomi

025-0075

Hanamaki

020-0103

Morioka

763-8502

Marugame

760-0018

Takamatsu

899-0131

Izumi

891-0116

Kagoshima

243-8551

Atsugi

251-0041

Fujisawa

251-8550

Fujisawa

247-8533

Kamakura

216-8511

Kawasaki

227-0046

Yokohama

231-8682

Yokohama

236-0037

Yokohama

236-0051

Yokohama

783-8509

Nangoku

860-0008

Kumamoto

602-8026

Kyoto

611-0042

Uji

511-0068

Kuwana

980-0803

Sendai

981-3107

Sendai

983-0821

Sendai

983-8512

Sendai

983-8520

Sendai

384-8588

Komoro

390-8510

Matsumoto

392-8510

Suwa

850-8555

Nagasaki

949-3193

Jōetsu

940-8621

Nagaoka

874-0011

Beppu

874-0901

Beppu

870-0021

Ōita

870-0192

Ōita

870-0263

Ōita

870-0917

Ōita

879-5593

Yufu

714-0043

Kasaoka

700-8558

Okayama

700-8607

Okayama

904-8585

Okinawa

901-0493

Shimajiri

574-0074

Daitō

578-8588

Higashiosaka

573-0153

Hirakata

573-8511

Hirakata

586-8521

Kawachi-Nagano

596-8522

Kishiwada

530-0001

Osaka

530-8480

Osaka

537-0011

Osaka

540-0006

Osaka

558-0011

Osaka

558-8558

Osaka

569-1096

Takatsuki

560-0022

Toyonaka

581-0011

Yao

348-8505

Hanyū

344-0035

Kasukage

364-8501

Kitamoto

359-1141

Tokorozawa

359-1142

Tokorozawa

351-0102

Wako

525-8585

Kusatsu

418-0076

Fujinomiya

437-0061

Fukuroi

432-8580

Hamamatsu

433-8558

Hamamatsu

438-8550

Iwata

427-8502

Shimada

421-0193

Shizuoka

422-8527

Shizuoka

424-8636

Shizuoka

772-8503

Narutochō-mitsuishi

770-0011

Tokushima

133-0052

Edogawa-ku

192-0045

Hachiōji

203-0033

Higashikurume

173-8610

Itabashi-ku

175-0082

Itabashi-ku

153-8515

Meguro-ku

145-0065

Ōta-ku

150-0013

Shibuya-ku

141-0001

Shinagawa-ku

162-8655

Shinjuku-ku

689-0203

Tottori-shi

930-0194

Toyama

640-8505

Wakayama

999-7782

Higashikawada

750-0061

Shimonoseki

745-8522

Shūnan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen R&D, L.L.C.

UNKNOWN

lead

Bayer

INDUSTRY