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A multicenter, prospective observational study to evaluate the clinical safety and effectiveness of Elxaban as anticoagulant in patients with non-valvular atrial fibrillation and ischemic stroke or transient ischemic attac

A multicenter, prospective observational study to evaluate the clinical safety and effectiveness of Elxaban in patients with non-valvular atrial fibrillation and ischemic stroke or transient ischemic attack

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011823
Enrollment
257
Registered
2026-04-08
Start date
2026-05-30
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

None listed

Interventions

None listed

Sponsors

Keimyung University Dongsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Adults aged 19 years or older at the time of providing written informed consent 2.Patients diagnosed with non-valvular atrial fibrillation 3.Patients diagnosed with ischemic stroke or transient ischemic attack 4.Patients requiring treatment with apixaban (Elsaban®) for the reduction of the risk of stroke and systemic embolism 5.Patients who voluntarily decide to participate in the study and provide written informed consent

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1.Patients with any contraindications listed in the precautions for use of apixaban (Elsaban®) 2.Patients prescribed apixaban (Elsaban®) at a dose not approved according to the product labeling 3.Patients diagnosed with moderate to severe mitral stenosis 4.Patients with a history of mechanical prosthetic heart valve replacement 5.Patients with any of the following laboratory abnormalities:    (1) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 × upper limit of normal (ULN)    (2) Total bilirubin = 1.5 × ULN    (3) Creatinine clearance (CrCl) < 15 mL/min 6.Pregnant or breastfeeding women 7.Patients with a history of anaphylaxis or severe hypersensitivity reactions 8.Patients with a history of substance abuse, including alcohol, or psychiatric disorders 9.Patients who have participated in another clinical trial within 90 days prior to screening 10.Patients with a life expectancy of less than 1 year 11.Patients deemed unsuitable for participation in the study by the investigator for any other reason

Design outcomes

Primary

MeasureTime frame
Incidence of major bleeding

Secondary

MeasureTime frame
Hemorrhagic strok;Ischemic stroke;Systemic embolism;Transient ischemic attack;All-cause mortality;Incidence of AEs and ADRs; incidence of bleeding-related AEs and ADRs

Countries

Korea, Republic of

Contacts

Public ContactNari Hyun

Keimyung University Dongsan Hospital

ellewoods070707@gmail.com+82-53-258-4648

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Apr 17, 2026