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

Ischemic Stroke Clinical Trial

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

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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03777631
Study type Interventional
Source Nippon Medical School
Contact
Status Active, not recruiting
Phase Phase 3
Start date April 1, 2018
Completion date March 31, 2026
View Details
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