UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031424
Receipt number R000035541
Scientific Title STroke secondary prevention with catheter ABLation and EDoxaban for patients with non-valvular atrial fibrillation
Date of disclosure of the study information 2018/03/01
Last modified on 2019/07/19 14:05:43

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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 or person

Institute

Nippon Medical School Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035541


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name