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Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort 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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000017895
Enrollment
3000
Registered
2015-06-13
Start date
2015-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-valvular atrial fibrillation (NVAF)

Interventions

None listed

Sponsors

The Cardiovascular Institute Academic Organization (CVI ARO)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Consecutive outpatients with 75 years and older receiving apixaban with a diagnosis of non-valvular atrial fibrillation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Stroke and systemic embolism Bleeding requiring hospitalization

Secondary

MeasureTime frame
Death Cardiovascular death Myocardial infarction Composite endpoints of cardiovascular death, myocardial infarction, stroke, and systemic embolism

Countries

Japan

Contacts

Public ContactKazumi Matsuda

The Cardiovascular Institute Academic Organization (CVI ARO) Head office

matsuda@cvi.or.jp03-3408-2151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026