臨床研究等提出・公開システム

Atrial Fibrillation-Related Ischemic Stroke Despite Anticoagulation-1 Prospective Cohort Study (AFIDA-1) (AFIDA-1)

AFIDA-1 (AFIDA-1)

Koga Masatoshi

National Cerebral and Cardiovascular Center

6-1 Kishibe-Shimmachi, Suita, Osaka

koga@ncvc.go.jp

tanaka kanta

Kindai University Hospital

1-14-1 Miharadai, Minami-ku, Sakai, Osaka

+81-72-288-7222

tanaka19830311kanta@gmail.com

Not Recruiting

Mar. 05, 2025

Observational

1) Patients with ischemic stroke or transient ische Inclusion Criteria mic attack (TIA) within 28 days of onset
2) Patients with NVAF who receive oral anticoagulation at the time of onset
3) Patients 18 years or older at the time of informed consent
4) Patients for whom written informed consent has been obtained from the person or proxy

1) Patients after mechanical valve replacement
2) Patients with severe mitral stenosis
3) Patients who have already participated or will participate in other clinical trials
4) Patients deemed by the physician to be unsuitable to participate in the study.

Both

Ischemic stroke, transient ischemic attack, non-valvular atrial fibrillation

Ischemic stroke, transient ischemic attack, non-valvular atrial fibrillation

D000083242, D002546, D001281

Incidence of the composite outcome of recurrent ischemic stroke /systemic embolism within 48 weeks of enrollment

1) Incidence of composite outcome of stroke and systemic embolism within 48 weeks of enrollment
2) Incidence of stroke within 48 weeks of enrollment
3) Incidence of disabling stroke (increased modified Rankin Scale [mRS]>=2) within 48 weeks of enrolment
4) Incidence of recurrent ischemic stroke within 48 weeks of enrollment
5) Incidence of recurrent disabling ischemic stroke (change in mRS>=2) within 48 weeks of enrollment
6) Incidence of systemic embolism within 48 weeks of enrollment
7) Incidence of cardiovascular death within 48 weeks of enrollment
8) Incidence of unexplained death within 48 weeks of enrollment
9) Incidence of cardiovascular death or unexplained death within 48 weeks of enrollment
10) Incidence of major bleeding within 48 weeks of enrollment
11) Incidence of intracranial hemorrhage within 48 weeks of enrolment
12) Incidence of major extracranial bleeding within 48 weeks of enrolment
13) Incidence of all-cause death within 48 weeks of enrolment

+81-6-6170-1069

Jan. 10, 2025

No

none