Unique ID issued by UMIN | UMIN000017895 |
---|---|
Receipt number | R000020733 |
Scientific Title | Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort Study |
Date of disclosure of the study information | 2015/06/13 |
Last modified on | 2020/06/17 09:05:23 |
Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort Study
J-ELD AF (CVI ARO 5) Study
Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort Study
J-ELD AF (CVI ARO 5) Study
Japan |
non-valvular atrial fibrillation (NVAF)
Cardiology |
Others
NO
To clarify the efficacy and safety of apixaban in Japanese elderly patients with NVAF in real-world clinical practice
Safety,Efficacy
Stroke and systemic embolism
Bleeding requiring hospitalization
Death
Cardiovascular death
Myocardial infarction
Composite endpoints of cardiovascular death, myocardial infarction, stroke, and systemic embolism
Observational
75 | years-old | <= |
Not applicable |
Male and Female
Consecutive outpatients with 75 years and older receiving apixaban with a diagnosis of non-valvular atrial fibrillation
(1) Apixaban hypersensitivity
(2) Clinically significant bleeding
(3) River dysfunction with clotting disorder
(4) Renal dysfunction (creatinine clearance <15 mL/min)
(5) Mitral stenosis and prosthetic valve
(6) Inadequate dosage of apixaban at registration (2.5 mg twice a day for those without indications for reducing dose, or 5 mg twice a day for those with them)
(7) Patients who did not give written informed consents for this study
(8) Venous thromboembolism (deep vein thrombosis and pulmonary thromboembolism)
(9) Patients who are judged by the researchers as inadequate for this study
3000
1st name | #3 Masaharu Akao |
Middle name | #2 Takeshi Yamashita |
Last name | #1 Ken Okumura |
#1 Hirosaki University Graduate School of Medicine
#2 The Cardiovascular Institute
#3 National Hospital Organization Kyoto Medical Center
#1 Professor, Department of Cardiology and Nephrology #2 Director #3 Department director, Department of Cardiology
106-0031
#2 3-2-19 Nishiazabu, Minato-Ku, Tokyo
+81-3-3408-2151
yamt-tky@umin.ac.jp
1st name | Kazumi |
Middle name | |
Last name | Matsuda |
The Cardiovascular Institute Academic Organization (CVI ARO)
Head office
106-0031
3-2-19 Nishiazabu, Minato-Ku, Tokyo
03-3408-2151
matsuda@cvi.or.jp
The Cardiovascular Institute Academic
Organization (CVI ARO)
Bristol-Myers Squibb
Outside Japan
United States
Ethical Committee of The Cardiovascular Institute
Nishi-azabu 3-2-19, Minato-ku, Tokyo
+81-3-3408-2151
matsuda@cvi.or.jp
NO
2015 | Year | 06 | Month | 13 | Day |
https://www.journal-of-cardiology.com/article/S0914-5087(15)00404-9/fulltext
Published
https://onlinelibrary.wiley.com/doi/full/10.1002/clc.23294
3031
Event rates (/100 person-years) in standard and reduced dose groups were 1.67 and 1.56, respectively, for stroke or systemic embolism, 1.42 and 2.25 for bleeding requiring hospitalization, 1.41 and 4.46 for total death, and 0.41 and 1.36 for cardiovascular death.
2020 | Year | 06 | Month | 17 | Day |
2019 | Year | 11 | Month | 18 | Day |
Average age, 81.7 years; female, 48.2%
Taking standard (5 mg bid) or reduced dose (2.5 mg bid) of apixaban.
Standard and reduced apixaban doses were administered in 1284 (42.4%) and 1747 (57.6%) patients, respectively.
A total of 3031 patients were enrolled from 110 facilities.
Shown in the Results above.
Shown in the Results above.
Completed
2015 | Year | 06 | Month | 13 | Day |
2015 | Year | 08 | Month | 27 | Day |
2015 | Year | 09 | Month | 01 | Day |
2017 | Year | 08 | Month | 31 | Day |
2018 | Year | 01 | Month | 31 | Day |
2018 | Year | 05 | Month | 31 | Day |
3031 patients have been registered,
and follow-up was completed
2015 | Year | 06 | Month | 13 | Day |
2020 | Year | 06 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020733
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