STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study
NCT03777631 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251
Last updated 2023-11-15
Summary
Catheter ablation (CA) has been reported to reduce risk of stroke in patients with nonvalvular atrial fibrillation (NVAF) in retrospective studies, but risk and benefit of CA has not been well elucidated in NVAF with recent cerebral infarction in prospective randomized trials.
Conditions
- Ischemic Stroke
- Atrial Fibrillation Non-Rheumatic
Interventions
- PROCEDURE
-
Catheter ablation
CA should be performed within 1-6 months from the onset of cerebral infarction. CA is based on pulmonary vein isolation, with atrial ablation as required.
Sponsors & Collaborators
-
Daiichi Sankyo Co., Ltd.
collaborator INDUSTRY -
Nippon Medical School
lead OTHER
Principal Investigators
-
Kazumi Kimura, M.D., Ph.D · Department of Neurology, Nippon Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
Countries
- Japan
Study Locations
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