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
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
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
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
