Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard medical therapy group | No Intervention | The preferred anticoagulant is edoxaban. Antiarrhythmic drugs are administered as needed for the patient by well-trained cardiologists. | |
| Catheter ablation group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of cerebral infarction | Recurrence of cerebral infarction | Up to 6 years |
| Systemic embolism | Symptomatic systemic embolism to other regions than brain, e.g. peripheral or visceral arteries |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (safety and tolerability) | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kazumi Kimura, M.D., Ph.D | Department of Neurology, Nippon Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ichinomiyanishi Hospital | Aichi | Japan | ||||
| Hirosaki Stroke and Rehabilitation Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41770549 | Derived | Kimura K, Nishiyama Y, Iwasaki YK, Shimizu W, Toyoda K, Sakamoto Y, Katano T, Yamamoto T, Takeuchi M, Kumagai K, Tsuto K, Sugi K, Kusano K, Koga M, Okubo S, Sato T, Hamaguchi H, Yoshida A, Kuriki A, Tanno K, Kitagawa K, Hagiwara N, Daida H, Iguchi Y, Fujimoto S, Miyamoto S, Fukuzawa M, Sugimoto M, Takita A, Otsuka T, Okumura K. Catheter Ablation and Oral Anticoagulation for Secondary Stroke Prevention in Atrial Fibrillation: The STABLED Randomized Clinical Trial. JAMA Neurol. 2026 Apr 1;83(4):329-338. doi: 10.1001/jamaneurol.2026.0155. | |
| 31337525 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The included patients were randomly allocated to two groups: (1) Standard medical treatment group and (2) Catheter ablation additional group.
Not provided
Not provided
Not provided
Not provided
| Up to 6 years |
| All-cause death | All-cause death | Up to 6 years |
| Cardiovascular death | Cardiovascular death | Up to 6 years |
| Hospitalization for heart failure | Hospitalization for heart failure | Up to 6 years |
| Any bleeding | Any bleeding | Up to 6 years |
| Intracranial hemorrhage | Intracranial hemorrhage | Up to 6 years |
| 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 |
| The rate of and related factors to discontinuation of Edoxaban | The rate of and related factors to discontinuation of Edoxaban | Up to 6 years |
| 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 |
Incidence of all adverse events, not restricted to CA maneuver-related adverse events
| Within 1 month after CA |
| Drug reaction to edoxaban | Drug reaction to edoxaban | Up to 6 years |
| 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided