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STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation (STABLED study)

STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation (STABLED study)

Iwasaki Yu-ki

Nippon Medical School Hospital

1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan

iwasaki@nms.ac.jp

Iwasaki Yu-ki

Nippon Medical School Hospital

1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan

+81-3-3822-2131

iwasaki@nms.ac.jp

Not Recruiting

Mar. 01, 2018

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1)Age >=20 and =<85 years at time of giving informed consent
2)Nonvalvular atrial fibrillation
3)History of ischemic stroke in previous 6 months
4)Current or planned treatment with edoxaban
5)Modified Rankin Scale (mRS) =<3

1)Symptomatic paroxysmal atrial fibrillation resistant to anti-arrhythmic drugs
2)Presence of left atrial thrombus and/or left atrial appendage on transthoracic echocardiography, computed tomography or magnetic resonance imaging
3)Unable to take anticoagulation therapy for any reason, including tendency to bleed or considered at high risk for bleeding from anticoagulation therapy
4)Presence of severe renal disorder(estimated creatinine clearance <30 mL/min by Cockroft-Gault equation)
5)Previous catheter ablation or surgical intervention for atrial fibrillation
6)History of treatment with a left atrial appendage closure device
7)Left atrial diameter >=55 mm on transthoracic echocardiography
8)Ejection fraction =<35% on transthoracic echocardiography
9)Persistent Sustained AF for >=10 years
10)Atrial septal defect (ASD)
11)Pregnant or possibility of pregnancy
12)Unlikely to complete the study, such as due to progressive malignant tumor
13)Participating or planning to participate in another interventional clinical trial
14)Unwilling to participate
15)Judged as incompatible for the study by the investigators

Both

Non-valvular atrial fibrillation

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

Catheter ablation additional group:
Catheter ablation should be performed from the onset of ischemic stroke. Catheter ablation is based on pulmonary vein isolation, with atrial ablation as required.

The following composite events during observation period
1) Recurrence of ischemic stroke
2) Systemic embolism
3) All-cause death
4) Hospitalization for heart failure

<<Secondary Endpoints>>
1)Onset of stroke
2)Recurrence of ischemic stroke
3)Hemorrhagic stroke
4)Systemic embolism
5) All-cause death
6)Cardiovascular death
7)Hospitalization for heart failure
8)Any bleeding(Major and minor bleeding, Major bleeding, Minor bleeding)
9)Onset of intracranial hemorrhage
10) Gastrointestinal bleeding
11)Composite events (all-cause death, onset of stroke, systemic embolism, hospitalization for heart failure, and serious adverse event caused by catheter ablation)

<<Other Endpoints>>
1)Modified Rankin scale score and NYHA classification at the end of observation period
2)Maintenance rate of sinus rhythm
3)Changes in Mini-Mental State Examination (MMSE) scores during observation period
4)The continuation rate of edoxaban
5)Recurrence rate of stroke according to whether or not Edoxaban discontinue
6)Factors which contribute to discontinue edoxaban

<<Safety outcomes>>
1)Serious adverse events related to catheter ablation maneuver
2)All adverse events not related to catheter ablation maneuver
3)Drug reaction to edoxaban

+81-3-3822-2131

Dec. 25, 2018

none