STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study

Ischemic Stroke Clinical Trial

— STABLED  

Official title:

STroke Secondary Prevention With Catheter ABLation and EDoxaban for Patients With Non-valvular Atrial Fibrillation: STABLED Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03777631
• Other study ID #: LIX-DS-16018
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1, 2018
• Est. completion date: March 31, 2026

Study information

• Verified date: November 2023
• Source: Nippon Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In patients with NVAF, stroke is an independent risk factor for a subsequent cerebral infarction. Although anticoagulant therapy can effectively reduce thromboembolic events, the reported annual recurrence rate in NVAF and previous stroke patients in the "real-world" is not low even with appropriate antithrombotic treatment; 8.6% in patients with "guideline adherent" antithrombotic therapy and around 5% in patients treated with anticoagulant therapy. NVAF and recent stroke is high-risk population for stroke recurrence even with anticoagulant therapy, and developing optimal secondary prevention strategy is an urgent task.

Catheter ablation (CA) is now widely used to treat symptoms related to NVAF. Some retrospective studies showed a beneficial effect of CA for stroke prevention using age-/sex-matching or propensity-score matching. Moreover, CA have a potential to improve survival or prevent heart failure development in patients with AF. However, the effect of CA for secondary stroke prevention or impact of CA for NVAF patients with recent ischemic stroke for survival or developing heart failure has not been evaluated in a prospective randomized trial. Therefore, in the present study, we intend to compare two groups of patients with NVAF with a history of cerebral infarction: a group receiving standard medical therapy (control group) and a group receiving standard medical therapy plus CA (CA group).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 251
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Non-Rheumatic
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Japan	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	Hyogo
Japan	Hyogo College of Medicine College Hospital	Hyogo
Japan	Kitaharima medical center	Hyogo
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

Sponsors (2)

Lead Sponsor	Collaborator
Nippon Medical School	Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment-emergent adverse events (safety and tolerability)	Incidence of treatment-emergent adverse events (safety and tolerability)	Within 1 month after CA
Other	Incidence of all adverse events, not restricted to CA maneuver-related adverse events	Incidence of all adverse events, not restricted to CA maneuver-related adverse events	Within 1 month after CA
Other	Drug reaction to edoxaban	Drug reaction to edoxaban	Up to 6 years
Primary	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	Recurrence of cerebral infarction	Recurrence of cerebral infarction	Up to 6 years
Secondary	Systemic embolism	Symptomatic systemic embolism to other regions than brain, e.g. peripheral or visceral arteries	Up to 6 years
Secondary	All-cause death	All-cause death	Up to 6 years
Secondary	Cardiovascular death	Cardiovascular death	Up to 6 years
Secondary	Hospitalization for heart failure	Hospitalization for heart failure	Up to 6 years
Secondary	Any bleeding	Any bleeding	Up to 6 years
Secondary	Intracranial hemorrhage	Intracranial hemorrhage	Up to 6 years
Secondary	Composite events	all-cause death, onset of stroke, systemic embolism, hospitalization for heart failure, and serious adverse event caused by CA	Up to 6 years
Secondary	The rate of and related factors to discontinuation of Edoxaban	The rate of and related factors to discontinuation of Edoxaban	Up to 6 years
Secondary	Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban	Recurrence of cerebral infarction in patients with or without discontinuation of Edoxaban	Up to 6 years