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

NCT ID: NCT00494871

Last Updated: 2015-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-01-31

Brief Summary

This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).

Detailed Description

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Rivaroxaban (Xarelto, BAY59-7939)

Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

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

Warfarin placebo

Intervention Type: DRUG

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

Warfarin

Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

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)

Rivaroxaban placebo

Intervention Type: DRUG

Participants orally administered a rivaroxaban placebo tablet

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Rivaroxaban placebo

Participants orally administered a rivaroxaban placebo tablet

Intervention Type: DRUG

Warfarin placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 20 years or older
• Japanese male or female
• Non- valvular atrial fibrillation documented by ECG
• Patients with a risk of stroke and non-CNS systemic embolism

Exclusion Criteria

• Significant mitral stenosis
• Patients in whom anticoagulants are contraindicated

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen R&D, L.L.C.

UNKNOWN

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Kasugai, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Nagoya, Aichi-ken, Japan

Okazaki, Aichi-ken, Japan

Goshogawara, Aomori, Japan

Hirosaki, Aomori, Japan

Hirosaki, Aomori, Japan

Asahi, Chiba, Japan

Funabashi, Chiba, Japan

Imba, Chiba, Japan

Matsudo, Chiba, Japan

Matsudo, Chiba, Japan

Yotsukaidō, Chiba, Japan

Imabari, Ehime, Japan

Matsuyama, Ehime, Japan

Matsuyama, Ehime, Japan

Matsuyama, Ehime, Japan

Niihama, Ehime, Japan

Saijō, Ehime, Japan

Tōon, Ehime, Japan

Fukui-shi, Fukui, Japan

Chikushi-gun, Fukuoka, Japan

Chikushino-shi, Fukuoka, Japan

Chikushino-shi, Fukuoka, Japan

Fukuoka, Fukuoka, Japan

Fukuoka, Fukuoka, Japan

Fukuoka, Fukuoka, Japan

Fukuoka, Fukuoka, Japan

Kasuga, Fukuoka, Japan

Kasuga, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Kurume, Fukuoka, Japan

Ogōri, Fukuoka, Japan

Yame, Fukuoka, Japan

Yame, Fukuoka, Japan

Kōriyama, Fukushima, Japan

Gifu, Gifu, Japan

Ōgaki, Gifu, Japan

Maebashi, Gunma, Japan

Mebashi, Gunma, Japan

Ōtake, Hiroshima, Japan

Asahikawa, Hokkaido, Japan

Chitose, Hokkaido, Japan

Hakodate, Hokkaido, Japan

Muroran, Hokkaido, Japan

Otaru, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Sunagawa, Hokkaido, Japan

Tomakomai, Hokkaido, Japan

Kobe, Hyōgo, Japan

Kobe, Hyōgo, Japan

Kobe, Hyōgo, Japan

Higashiibaraki, Ibaraki, Japan

Hitachi, Ibaraki, Japan

Jōsō, Ibaraki, Japan

Kasama, Ibaraki, Japan

Moriya, Ibaraki, Japan

Namegata, Ibaraki, Japan

Toride, Ibaraki, Japan

Kanazawa, Ishikawa-ken, Japan

Nomi, Ishikawa-ken, Japan

Hanamaki, Iwate, Japan

Morioka, Iwate, Japan

Marugame, Kagawa-ken, Japan

Takamatsu, Kagawa-ken, Japan

Izumi, Kagoshima-ken, Japan

Kagoshima, Kagoshima-ken, Japan

Atsugi, Kanagawa, Japan

Fujisawa, Kanagawa, Japan

Fujisawa, Kanagawa, Japan

Kamakura, Kanagawa, Japan

Kawasaki, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Nangoku, Kochi, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Uji, Kyoto, Japan

Kuwana, Mie-ken, Japan

Sendai, Miyagi, Japan

Sendai, Miyagi, Japan

Sendai, Miyagi, Japan

Sendai, Miyagi, Japan

Sendai, Miyagi, Japan

Komoro, Nagano, Japan

Matsumoto, Nagano, Japan

Suwa, Nagano, Japan

Nagasaki, Nagasaki, Japan

Jōetsu, Niigata, Japan

Nagaoka, Niigata, Japan

Beppu, Oita Prefecture, Japan

Beppu, Oita Prefecture, Japan

Ōita, Oita Prefecture, Japan

Ōita, Oita Prefecture, Japan

Ōita, Oita Prefecture, Japan

Ōita, Oita Prefecture, Japan

Yufu, Oita Prefecture, Japan

Kasaoka, Okayama-ken, Japan

Okayama, Okayama-ken, Japan

Okayama, Okayama-ken, Japan

Okinawa, Okinawa, Japan

Shimajiri, Okinawa, Japan

Daitō, Osaka, Japan

Higashiosaka, Osaka, Japan

Hirakata, Osaka, Japan

Hirakata, Osaka, Japan

Kawachi-Nagano, Osaka, Japan

Kishiwada, Osaka, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Osaka, Osaka, Japan

Takatsuki, Osaka, Japan

Toyonaka, Osaka, Japan

Yao, Osaka, Japan

Hanyū, Saitama, Japan

Kasukage, Saitama, Japan

Kitamoto, Saitama, Japan

Tokorozawa, Saitama, Japan

Tokorozawa, Saitama, Japan

Wako, Saitama, Japan

Kusatsu, Shiga, Japan

Fujinomiya, Shizuoka, Japan

Fukuroi, Shizuoka, Japan

Hamamatsu, Shizuoka, Japan

Hamamatsu, Shizuoka, Japan

Iwata, Shizuoka, Japan

Shimada, Shizuoka, Japan

Shizuoka, Shizuoka, Japan

Shizuoka, Shizuoka, Japan

Shizuoka, Shizuoka, Japan

Narutochō-mitsuishi, Tokushima, Japan

Tokushima, Tokushima, Japan

Edogawa-ku, Tokyo, Japan

Hachiōji, Tokyo, Japan

Higashikurume, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Meguro-ku, Tokyo, Japan

Ōta-ku, Tokyo, Japan

Shibuya-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Tottori-shi, Tottori, Japan

Toyama, Toyama, Japan

Wakayama, Wakayama, Japan

Higashikawada, Yamagata, Japan

Shimonoseki, Yamaguchi, Japan

Shūnan, Yamaguchi, Japan

Countries

Japan

References

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Other Identifiers

12620

Identifier Type: -

Identifier Source: org_study_id