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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029693
Receipt No. R000033933
Scientific Title Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation.
Date of disclosure of the study information 2017/10/25
Last modified on 2019/04/01

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Basic information
Public title Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation.
Acronym KYU-RABLE STUDY
Scientific Title Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation.
Scientific Title:Acronym KYU-RABLE STUDY
Region
Japan

Condition
Condition patients with non-valvular atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will consider and evaluate multicenter collaborative clinical research for safety and effectiveness of oral anti-Xa inhibitorin edoxaban by catheter ablation perioperative period for patients with non-valvular atrial fibrillation.
Secondarily, We will consider variation of thrombotic / thrombolytic biomarkers by catheter ablation perioperative period.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Combination of thromboembolic events (Stroke / systemic embolism) and major bleeding for 4 weeks from the date of catheter ablation.
Key secondary outcomes 1) The following expression rate events for 4 weeks from the date of by catheter ablation.
-All death
-Stroke / systemic embolism
-Major bleeding
-Clinically relevant non major bleeding
-Minor bleeding
-Cardiovascular events
-All adverse events
2) The variation of thrombotic / thrombolytic biomarkers by catheter ablation perioperative period.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Method for administration of Edoxaban
Until the day before catheter ablation : Oral administration for 4 weeks or more is performed every morning.
The day of catheter ablation : After the ablation, hemostasis is confirmed at the puncture site, and oral administration is performed.
The next day of catheter ablation : Oral administration 12 hour after the administration on the day of the ablation.
After two days later : Oral administration for 4 weeks or more is performed every morning.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient definitively diagnosed as non-valvular atrial fibrillation.
2) Patients scheduled to undergo catheter ablation for non-valvular atrial fibrillation.
3) Patients who have given informed consent in writing from oneself.( 20 years of age or older)
Key exclusion criteria (1) Patients falling under the administration contraindication for non-valvular atrial fibrillation of Edoxaban formulation.
(2) Patients who are creatinine clearance <30 mL/min.
(3) Patients contraindicated to undergo catheter ablation.
(4) Patients who developed thromboembolism or myocardial infarction within 2 months before registration.
(5) Patients who can't interrupt administration of antiplatelet drugs one week before catheter ablation is performed.
(6) Patients of CHADS2 score is 6 points.
Such as 18 items.
Target sample size 550

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohiko Takahashi
Organization Oita University Medical School
Division name Department of Cardiology Clinical laboratory diagnostic lecture course Professor
Zip code
Address 1-1 Hasamamachiidaigaoka, Yufu-city, Oita-prefecture, 879-5593,Japan
TEL 097-549-4411
Email maejima.tetsuya.j3@rdn.daiichisankyo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Maejima
Organization DAIICHI SANKYO RD NOVARE CO., LTD.
Division name Clinical Development Group3 Clinical Development Department
Zip code
Address 1-2-58,Hiromachi, Shinagawa-ku Tokyo 140-8710,Japan
TEL 03-5436-8543
Homepage URL
Email maejima.tetsuya.j3@rdn.daiichisankyo.co.jp

Sponsor
Institute DAIICHI SANKYO CO., LTD.
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
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 25 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 541
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 Completed
Date of protocol fixation
2017 Year 09 Month 26 Day
Date of IRB
2017 Year 11 Month 12 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2018 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 24 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033933

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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