STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study
STABLED
1 other identifier
interventional
251
1 country
46
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2018
Longer than P75 for phase_3
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 3, 2018
CompletedFirst Posted
Study publicly available on registry
December 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedNovember 15, 2023
November 1, 2023
8 years
November 3, 2018
November 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.
Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure.
Up to 6 years
Secondary Outcomes (10)
Recurrence of cerebral infarction
Up to 6 years
Systemic embolism
Up to 6 years
All-cause death
Up to 6 years
Cardiovascular death
Up to 6 years
Hospitalization for heart failure
Up to 6 years
- +5 more secondary outcomes
Other Outcomes (3)
Incidence of treatment-emergent adverse events (safety and tolerability)
Within 1 month after CA
Incidence of all adverse events, not restricted to CA maneuver-related adverse events
Within 1 month after CA
Drug reaction to edoxaban
Up to 6 years
Study Arms (2)
Standard medical therapy group
NO INTERVENTIONThe preferred anticoagulant is edoxaban. Antiarrhythmic drugs are administered as needed for the patient by well-trained cardiologists.
Catheter ablation group
ACTIVE COMPARATORCatheter 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. For conducting CA by a trained and experienced cardiologist, only institutions in which performed \>100 CA annually were participated in the present study in principle.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥20 or ≤85 years at time of giving informed consent
- Nonvalvular atrial fibrillation
- History of stroke in previous 6 months
- Current or planned treatment with edoxaban
- Modified Rankin scale ≤3
You may not qualify if:
- Symptomatic paroxysmal AF resistant to anti-arrhythmic drugs
- Presence of left atrial thrombus and left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
- Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy.
- Presence of severe renal disorder (estimated creatinine clearance \<30 mL/min by Cockroft-Gault equation)
- Previous CA or surgical intervention for AF
- History of treatment with a left atrial appendage closure device
- Left atrial diameter ≥55 mm on transthoracic echocardiography
- Ejection fraction ≤35% on transthoracic echocardiography
- Persistent AF for ≥10 years
- Pregnant or possibility of pregnancy
- Unlikely to complete the study, such as due to progressive malignant tumor
- Participating or planning to participate in another clinical trial
- Unwilling to participates
- Judged as incompatible for the study by the investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nippon Medical Schoollead
- Daiichi Sankyo Co., Ltd.collaborator
Study Sites (46)
Ichinomiyanishi Hospital
Aichi, Japan
Hirosaki Stroke and Rehabilitation Center
Aomori, Japan
Hirosaki University Hospital
Aomori, Japan
Kimitsu Chuo Hospital
Chiba, Japan
New Tokyo Heart Clinic
Chiba, Japan
New Tokyo Hospital
Chiba, Japan
Nippon Medical School Chiba Hokusoh Hospital
Chiba, Japan
Kokura Memorial Hospital
Fukuoka, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
Ogaki Municipal Hospital
Gifu, Japan
Brain Attack Center Ota Memorial Hospital
Hiroshima, Japan
Fukuyama Cardiovascular Hospital
Hiroshima, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
Hiroshima University Hospital
Hiroshima, Japan
Suiseikai Kajikawa Hospital
Hiroshima, Japan
Teine Keijinkai Hospital
Hokkaido, Japan
Hyogo Brain and Heart Center
Hyōgo, Japan
Hyogo College of Medicine College Hospital
Hyōgo, Japan
Kitaharima medical center
Hyōgo, Japan
Odawara Cardiovascular Hospital
Kanagawa, Japan
Seisho Hospital
Kanagawa, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Japan
Kumamoto Red Cross Hospital
Kumamoto, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Japan
Iwate Medical University
Morioka, Japan
Iwate Prefectural Central Hospital
Morioka, Japan
Nagasaki University Hospital
Nagasaki, Japan
Tenri Hospital
Nara, Japan
Okayama Red Cross Hospital
Okayama, Japan
National Cerebral and Cardiovascular Center
Osaka, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Osaka General Medical Center
Osaka, Japan
Saga Medical Center Koseikan
Saga, Japan
Saitama Medical Center
Saitama, Japan
Saitama Medical University International Medical Center
Saitama, Japan
Dokkyo Medical University Hospital
Tochigi, Japan
Jichi Medical University Hospital
Tochigi, Japan
Jikei University Hospital
Tokyo, Japan
Juntendo University Hospital
Tokyo, Japan
Kyorin University Hospital
Tokyo, Japan
Nippon Medical School
Tokyo, Japan
NTT Medical Center Tokyo
Tokyo, Japan
Showa University Koto Toyosu Hospital
Tokyo, Japan
Tokyo Women's Medical University Hospital
Tokyo, Japan
Tsuruoka Kyoritsu Hospital
Yamagata, Japan
Tsuruoka Municipal Shonai Hospital
Yamagata, Japan
Related Publications (1)
Sakamoto Y, Nishiyama Y, Iwasaki YK, Daida H, Toyoda K, Kitagawa K, Okumura K, Kusano K, Hagiwara N, Fujimoto S, Miyamoto S, Otsuka T, Iguchi Y, Kanamaru T, Yamamoto T, Kaburagi J, Kimura T, Matsumoto T, Kimura K, Shimizu W; STABLED Study Investigators. Design and rationale of the STroke secondary prevention with catheter ABLation and EDoxaban clinical trial in patients with non-valvular atrial fibrillation: The STABLED study. J Cardiol. 2019 Dec;74(6):539-542. doi: 10.1016/j.jjcc.2019.06.002. Epub 2019 Jul 20.
PMID: 31337525DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kazumi Kimura, M.D., Ph.D
Department of Neurology, Nippon Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 3, 2018
First Posted
December 17, 2018
Study Start
April 1, 2018
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
November 15, 2023
Record last verified: 2023-11