UMIN-CTR Clinical Trial

Basic information
Public title	STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation
Acronym	STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation: STABLED study
Scientific Title	STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation
Scientific Title:Acronym	STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation: STABLED study
Region	Japan

Condition
Condition	non-valvular atrial fibrillation
Classification by specialty	Cardiology Neurology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify efficacy and safety of catheter ablation added to anticoagulation therapy with Edoxaban in patients with non-valvular atrial fibrillation with a history of ischemic stroke in a multicenter cooperative prospective randomized comparative study. In addition, we clarify factors influencing the discontinuation of Edoxaban and prognosis when it is discontinued for each non-valvular atrial fibrillation with or without catheter ablation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	The following composite events during observation period 1: Recurrence of ischemic stroke 2: Systemic embolism 3: All cause death 4: Hospitalization by Heart Failure
Key secondary outcomes	<<Secondary Endpoints>> 1: Onset of stroke 2: Recurrence of ischemic stroke 3: Systemic embolism 4: All cause death 5: Cardiovascular death 6: Hospitalization by Heart Failure 7: Any bleeding 8: Onset of intracranial hemorrhage 9: Composite events (all cause death, onset of stroke, systemic embolism, hospitalization by Heart Failure, serious adverse event caused by catheter ablation) <<The 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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Standard medication Group: Anticoagulation therapy should be Edoxaban. In addition, antiarrhythmic drugs are appropriately administered depending on the condition. Dosage is according to the package insert of the drug to be used.
Interventions/Control_2	Catheter ablation additional Group: Catheter ablation should be performed within 1 month to 6 months from the onset of ischemic stroke. Catheter ablation is based on pulmonary vein isolation and adds atrial ablation as needed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) 20<=, 80> aged patients at the time of obtaining the informed consent 2) Patients with non-valvular atrial fibrillation 3) have a history of a prior stroke within 6 months before enrolment 4) Patients who is being treated or will be treated with Edoxaban 5) Patients with modified Rankin Scale under 3
Key exclusion criteria	1) Patients who have symptomatic paroxysmal atrial fibrillation and drug resistant 2) Patients who have Left Atrial Thrombus and left atrial appendage by transthoracic echocardiography, Computed Tomography(CT),Magnetic Resonance Imaging(MRI) 3) Patients who have a tendency to bleed or bleed and are considered to be at high risk of bleeding due to anticoagulation therapy. For other reasons, patients who cannot conduct anticoagulation therapy 4) Patients who are suffering from severe renal disorder (Ccr*<30mL/min) *Cockroft-Gault Equation 5) Patients who have undergone catheter ablation or surgical intervention for AF 6) Patients who have a treatment history with left atrial appendage closure device 7) Patients who have a left atrial diameter;55mm<= with transthoracic echocardiography 8) Patients who have ejection fraction;35%>= with transthoracic echocardiography 9) Persistent non-valvular atrial fibrillation over 10 years 10)Patients who have atrial septal defect 11) Patients who are pregnant and of child-bearing potential 12) Patients who are unlikely to complete research, such as progressive malignant tumor 13) Patients who is being participated or will be participated to other clinical trials 14) Patients who do not agree the study inclusion 15) Patients judged as inappropriate for this study by investigators
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Kazumi Middle name Last name Kimura
Organization	Nippon Medical School Hospital
Division name	Department of Neurological Science
Zip code	113-8602
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	k-kimura@nms.ac.jp

Public contact
Name of contact person	1st name Kaoru Middle name Last name Okabe
Organization	EP-CRSU Co.,Ltd
Division name	Clinical Research Headquaters, Management Department 2 Section1
Zip code	162-0814
Address	Acropolis TOKYO Bldg., 6-29 Shinogawamachi, Shinjuku-ku, Tokyo
TEL	03-5804-5045
Homepage URL
Email	okabe121@eps.co.jp

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

Funding Source
Organization	DAIICHI SANKYO CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Nippon Medical School Foundation
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel	03-5802-8202
Email	officetokutei@nms.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs031180249
Org. issuing International ID_1	jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 01 Month 05 Day
Date of IRB	2018 Year 02 Month 28 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 22 Day
Last modified on	2019 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035541