UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory Study to Evaluate the Effect of Uninterrupted Anticoagulants in Catheter Ablation Procedure for Non-valvular Atrial Fibrillation - Comparison between Rivaroxaban and Warfarin -
Title of the study (Brief title)	A Study on Anticoagulant Therapy in Catheter Ablation for Atrial Fibrillation - Rivaroxaban vs. Warfarin : A Comparative Study -
Region	Japan

Condition
Condition	Non-valvular Atrial Fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the thromboembolism/bleeding profile of anticoagulant therapy with rivaroxaban by contrast with that of warfarin in subjects with non-valvular atrial fibrillation who undergo catheter ablation procedure, as measured by the incidence rate of ablation-related asymptomatic cerebral infarction and post-procedural major bleeding event.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	the incidence of asymptomatic cerebral infarction caused by catheter ablation
Key secondary outcomes	1. the occurrence of post-procedural (30-40 days) major bleeding event 2. the occurrence of post-procedural (30-40 days) thromboembolic event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rivaroxavan will be orally administered at a dose of 15 mg once daily after evening meal. The administration will start one month before ablation and last until one month after that.
Interventions/Control_2	Warfarin will be orally administered once daily after evening meal. The dose of warfarin should be adjusted to achieve and maintain PT-INR in the therapeutic range of 2.0 to 3.0. The administration will start one month before ablation and last until one month after that.
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	Patients who fulfill all of the following criteria 1. Be diagnosed non-valvular atrial fibrillation 2. Be scheduled for catheter ablation procedure for AF 3. Has a left atrial diameter <= 55 mm 4. Be aged from 20 to 80 years 5. Sign an informed consent document by himself/herself
Key exclusion criteria	Patients who fulfill at least one of the following criteria 1. Has a history of a prior stroke or TIA within 6 months before enrollment 2. Has a history of a major bleeding within 12 months before enrollment 3. Has had major surgery including CABG within 6 months before enrollment 4. Has a history of a MI within 2 months before catheter ablation procedure 5. Has a CrCl < 30 mL/min at screening 6. Has a diagnosis or clinical condition requiring use of dual anti-platelet therapy 7. Has contraindications of rivaroxaban or warfarin 8. Be a patient judged as "inappropriate" by an investigator
Target sample size	200

Research contact person
Name of lead principal investigator	Seiji Takatsuki
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Address	35 Shinanomachi Shinjuku Tokyo
TEL	03-5843-6702
Email	seiji.takatsuki@gmail.com

Public contact
Name of contact person	Seiji Takatsuki
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Address	35 Shinanomachi Shinjuku Tokyo
TEL	03-5843-6702
Homepage URL
Email	seiji.takatsuki@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

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	慶応義塾大学病院(東京都)、東京医療センター(東京都)

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 20 Day
Anticipated trial start date	2014 Year 06 Month 16 Day
Last follow-up date	2016 Year 02 Month 29 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2017 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 03 Month 05 Day
Last modified on	2018 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015566