PMID- 25912695
OWN - NLM
STAT- MEDLINE
DCOM- 20160301
LR  - 20220419
IS  - 1347-4820 (Electronic)
IS  - 1346-9843 (Linking)
VI  - 79
IP  - 6
DP  - 2015
TI  - Apixaban for the Treatment of Japanese Subjects With Acute Venous Thromboembolism 
      (AMPLIFY-J Study).
PG  - 1230-6
LID - 10.1253/circj.CJ-15-0195 [doi]
AB  - 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, 70.4%). [corrected]. 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.
FAU - Nakamura, Mashio
AU  - Nakamura M
AD  - Department of Cardiology and Nephrology, Mie University Graduate School of 
      Medicine.
FAU - Nishikawa, Masakatsu
AU  - Nishikawa M
FAU - Komuro, Issei
AU  - Komuro I
FAU - Kitajima, Isao
AU  - Kitajima I
FAU - Uetsuka, Yoshio
AU  - Uetsuka Y
FAU - Yamagami, Takuji
AU  - Yamagami T
FAU - Minamiguchi, Hiroki
AU  - Minamiguchi H
FAU - Yoshimatsu, Rika
AU  - Yoshimatsu R
FAU - Tanabe, Kosuke
AU  - Tanabe K
FAU - Matsuoka, Nobushige
AU  - Matsuoka N
FAU - Kanmuri, Kazuhiro
AU  - Kanmuri K
FAU - Ogawa, Hisao
AU  - Ogawa H
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150424
PL  - Japan
TA  - Circ J
JT  - Circulation journal : official journal of the Japanese Circulation Society
JID - 101137683
RN  - 0 (Anticoagulants)
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyridones)
RN  - 3Z9Y7UWC1J (apixaban)
RN  - 5Q7ZVV76EI (Warfarin)
RN  - 9005-49-6 (Heparin)
SB  - IM
EIN - Circ J. 2015;79(11):2520. PMID: 26497167
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/adverse effects/therapeutic use
MH  - Factor Xa Inhibitors/adverse effects/*therapeutic use
MH  - Female
MH  - Hemorrhage/chemically induced
MH  - Heparin/adverse effects/therapeutic use
MH  - Humans
MH  - International Normalized Ratio
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Pulmonary Embolism/*drug therapy
MH  - Pyrazoles/adverse effects/*therapeutic use
MH  - Pyridones/adverse effects/*therapeutic use
MH  - Recurrence
MH  - Treatment Outcome
MH  - Venous Thromboembolism/*drug therapy
MH  - Venous Thrombosis/*drug therapy
MH  - Warfarin/adverse effects/therapeutic use
EDAT- 2015/04/29 06:00
MHDA- 2016/03/02 06:00
CRDT- 2015/04/28 06:00
PHST- 2015/04/28 06:00 [entrez]
PHST- 2015/04/29 06:00 [pubmed]
PHST- 2016/03/02 06:00 [medline]
AID - 10.1253/circj.CJ-15-0195 [doi]
PST - ppublish
SO  - Circ J. 2015;79(6):1230-6. doi: 10.1253/circj.CJ-15-0195. Epub 2015 Apr 24.