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Clinical Trials/JPRN-UMIN000014230
JPRN-UMIN000014230Completed未知

Intracranial hemorrhage during the novel oral anticoagulants treatment: a nationwide, multicenter, retrospective cohort study in Japan - Intracranial hemorrhage during the novel oral anticoagulants treatment: a nationwide, multicenter, retrospective cohort study in Japan

Department of Stroke Medicine, Kawasaki Medical School0 sites50 target enrollmentStarted: June 15, 2014Last updated:

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
50

Study Overview

Brief Summary

Background:We conducted a multicenter retrospective cohort study to elucidate the characteristics of intracranial hemorrhage (ICH) in patients with atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants (NOACs). Methods and Results:We sent a questionnaire to the directors of 241 stroke centers in Japan to establish the clinical characteristics of NOAC-associated cerebral hemorrhage (CH), including hematoma size, hematoma enlargement (HE) and in-hospital mortality of patients treated in their institutions. We undertook a literature review to establish the clinical characteristics of warfarin-associated CH and compared these with our data. We received 174 responses (72.2%), of which 67 (38.5%) gave anonymous details of 130 eligible patients (male, 67.7%; mean age, 77.3+-8.3 years, in-hospital mortality rate, 11.5%). We judged that 87 of the 130 patients had presented with CH: one-fifth had taken antiplatelet drugs. We found that the incidences of HE and mortality in the 87 patients presenting with NOAC-associated CH were lower than would have been expected in those with warfarin-associated CH (17% vs. 26%, and 16% vs. 35%, respectively). Conclusions:More than half the stroke center directors who responded to our questionnaire had not experienced cases of NOAC-associated ICH. Compared with warfarin, NOACs appear to present a lower risk of HE and death in patients with atrial fibrillation who develop CH.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
ot applicable to ot applicable (—)
Sex
All

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Doctors who did not agree the present questionnaire survey

Investigators

Sponsor
Department of Stroke Medicine, Kawasaki Medical School

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