Apixaban for the Treatment of Japanese Subjects With Acute Venous Thromboembolism (AMPLIFY-J Study)

• Nakamura Mashio

  Department of Cardiology and Nephrology, Mie University Graduate School of Medicine

• Nishikawa Masakatsu

  Clinical Research Support Center, Mie University Hospital

• Komuro Issei

  Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine

• Kitajima Isao

  Department of Clinical Laboratory and Molecular Pathology, Graduate School of Medical and Pharmaceutical Science, University of Toyama

• Uetsuka Yoshio

  Department of Health Service and Hospital Administration, Tokyo Women’s Medical University

• Yamagami Takuji

  Department of Radiology, Kochi Medical School, Kochi University

• Minamiguchi Hiroki

  Department of Radiology, Wakayama Medical University

• Yoshimatsu Rika

  Department of Radiology, Kochi Medical School, Kochi University

• Tanabe Kosuke

  Clinical Research, Development Japan, Pfizer Japan

• Matsuoka Nobushige

  Clinical Statistics, Development Japan, Pfizer Japan

• Kanmuri Kazuhiro

  Clinical Research, Development Japan, Pfizer Japan

• Ogawa Hisao

  Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University National Cerebral and Cardiovascular Center

Bibliographic Information

Other Title

• LATE BREAKING CLINICAL TRIAL (JCS 2015) : Apixaban for the Treatment of Japanese Subjects With Acute Venous Thromboembolism (AMPLIFY-J Study)

Abstract

Background:Anticoagulation is recommended as standard of care for venous thromboembolism (VTE) (pulmonary embolism [PE]/deep vein thrombosis [DVT]), for which unfractionated heparin (UFH) and warfarin are used in Japan. In the multi-regional AMPLIFY study, a fixed-dose regimen of apixaban alone was non-inferior to conventional therapy for treatment of PE/DVT and was associated with significantly fewer bleeding events.Methods and Results:Japan phase 3 study (AMPLIFY-J), randomized, active-controlled, open-label study in Japanese subjects with acute PE/DVT, was designed based on AMPLIFY. Key objectives were to investigate safety and efficacy of apixaban in symptomatic PE/DVT subjects during 24-week treatment. UFH/warfarin was used as control treatment. Apixaban was initiated at 10 mg twice daily for 7 days, followed by 5 mg twice daily for 23 weeks. All endpoints and imaging for thrombotic burden were assessed by an event adjudication committee. Eighty subjects were randomized, 33 subjects (41.3%) were aged <65 years. Proportion of major/clinically relevant non-major bleeding was lower in apixaban (7.5%) compared with well-controlled UFH/warfarin (28.2%; median TTR, 70.1%). Recurrent VTE occurred in no subjects in apixaban and in 1 subject in UFH/warfarin. Thrombotic burden results were similar in both groups. Proportions of subjects with adverse events was generally similar in both groups.Conclusions:Apixaban was well-tolerated and had a favorable safety profile. No clinically important efficacy difference compared with UFH/warfarin was observed. (Circ J 2015; 79: 1230–1236)

Journal

• Circulation Journal

  Circulation Journal 79 (6), 1230-1236, 2015

  The Japanese Circulation Society

Keywords

• Apixaban
• Deep vein thrombosis
• Japanese
• Oral anticoagulant
• Pulmonary embolism

Details

• CRID: 1390001205106272256
• NII Article ID: 130005073151
• NII Book ID: AA11591968
• DOI: 10.1253/circj.cj-15-0195
• ISSN: 13474820
• ISSN: 13469843
• NDL BIB ID: 026398625
• PubMed: 25912695
• Web Site: http://id.ndl.go.jp/bib/026398625
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I026398625
• Web Site: https://www.jstage.jst.go.jp/article/circj/79/6/79_CJ-15-0195/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2015333533
• Text Lang: en
• Data Source:
  • JaLC
  • NDL
  • Crossref
  • PubMed
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed