UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000017895 |
| Receipt No. | 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 (Ver. 12) |
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| Basic information | ||
| Public title | Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort Study | |
| Acronym | J-ELD AF (CVI ARO 5) Study | |
| Scientific Title | Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort Study | |
| Scientific Title:Acronym | J-ELD AF (CVI ARO 5) Study | |
| Region |
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| Condition | ||
| Condition | non-valvular atrial fibrillation (NVAF) | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To clarify the efficacy and safety of apixaban in Japanese elderly patients with NVAF in real-world clinical practice |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Stroke and systemic embolism
Bleeding requiring hospitalization |
| Key secondary outcomes | Death
Cardiovascular death Myocardial infarction Composite endpoints of cardiovascular death, myocardial infarction, stroke, and systemic embolism |
| Base | |
| Study type | Observational |
| Study design | |
| Basic design | |
| Randomization | |
| Randomization unit | |
| Blinding | |
| Control | |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | |
| No. of arms | |
| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
| Interventions/Control_2 | |
| Interventions/Control_3 | |
| Interventions/Control_4 | |
| Interventions/Control_5 | |
| Interventions/Control_6 | |
| Interventions/Control_7 | |
| Interventions/Control_8 | |
| Interventions/Control_9 | |
| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| Gender | Male and Female | |||
| Key inclusion criteria | Consecutive outpatients with 75 years and older receiving apixaban with a diagnosis of non-valvular atrial fibrillation | |||
| Key exclusion criteria | (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 |
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| Target sample size | 3000 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | #1 Hirosaki University Graduate School of Medicine
#2 The Cardiovascular Institute #3 National Hospital Organization Kyoto Medical Center |
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| Division name | #1 Professor, Department of Cardiology and Nephrology #2 Director #3 Department director, Department of Cardiology | ||||||
| Zip code | 106-0031 | ||||||
| Address | #2 3-2-19 Nishiazabu, Minato-Ku, Tokyo | ||||||
| TEL | +81-3-3408-2151 | ||||||
| yamt-tky@umin.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | The Cardiovascular Institute Academic Organization (CVI ARO) | ||||||
| Division name | Head office | ||||||
| Zip code | 106-0031 | ||||||
| Address | 3-2-19 Nishiazabu, Minato-Ku, Tokyo | ||||||
| TEL | 03-3408-2151 | ||||||
| Homepage URL | |||||||
| matsuda@cvi.or.jp | |||||||
| Sponsor | |
| Institute | The Cardiovascular Institute Academic
Organization (CVI ARO) |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Bristol-Myers Squibb |
| Organization | |
| Division | |
| Category of Funding Organization | Outside Japan |
| Nationality of Funding Organization | United States |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Ethical Committee of The Cardiovascular Institute |
| Address | Nishi-azabu 3-2-19, Minato-ku, Tokyo |
| Tel | +81-3-3408-2151 |
| matsuda@cvi.or.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
| Org. issuing International ID_1 | |
| Study ID_2 | |
| Org. issuing International ID_2 | |
| IND to MHLW | |
| Institutions | |
| Institutions | |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | https://www.journal-of-cardiology.com/article/S0914-5087(15)00404-9/fulltext |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://onlinelibrary.wiley.com/doi/full/10.1002/clc.23294 | ||||||
| Number of participants that the trial has enrolled | 3031 | ||||||
| Results | 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. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results |
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| Baseline Characteristics | 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. |
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| Participant flow | A total of 3031 patients were enrolled from 110 facilities. |
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| Adverse events | Shown in the Results above. |
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| Outcome measures | Shown in the Results above. |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded | |||||||
| Other | |
| Other related information | 3031 patients have been registered,
and follow-up was completed |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020733 |
