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

NCT ID: NCT03777631

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2026-03-31

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.

Detailed 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).

Conditions

Ischemic Stroke; Atrial Fibrillation Non-Rheumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard medical therapy group

The preferred anticoagulant is edoxaban. Antiarrhythmic drugs are administered as needed for the patient by well-trained cardiologists.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Catheter ablation group

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. 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.

Group Type: ACTIVE_COMPARATOR

Catheter ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Nippon Medical School

OTHER

Sponsor Role: lead

Responsible Party

Kazumi Kimura

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kazumi Kimura, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Nippon Medical School

Locations

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

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 31337525 (View on PubMed)

Other Identifiers

LIX-DS-16018

Identifier Type: -

Identifier Source: org_study_id