UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Safety and Efficacy of Periprocedural Use of Rivaroxaban and Apixaban in Catheter Ablation for Atrial Fibrillation
Title of the study (Brief title)	Anticoagulants in atrial fibrillation ablation
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to compare the incidence of asymptomatic cerebral microthromboembolism and hemopericardium in AF ablation among periprocedural use of rivaroxaban, apixaban, and warfarin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Asymptomatic cerebral microthromboembolism on the day after AF ablation procedure
Key secondary outcomes	hemopericardium in AF ablation

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
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients taking NOACs upon visiting our hospital were randomly assigned into 2 groups; rivaroxaban and apixaban.
Interventions/Control_2	Patients taking NOACs upon visiting our hospital were randomly assigned into 2 groups; rivaroxaban and apixaban.
Interventions/Control_3	Warfarin was continued in patients taking warfarin.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	the patients who undergo AF ablation
Key exclusion criteria	thrombosis in cardium
Target sample size	150

Research contact person
Name of lead principal investigator	Mitsuru Ohishi
Organization	Kagoshima University
Division name	Department of Cardiovascular Medicine and Hypertension, Research Field in Medicine and Health Sciences
Address	Sakuragaoka 8-35-1, Kagoshima
TEL	099-275-5318
Email	iriki3@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Yasuhisa Iriki
Organization	Kagoshima University
Division name	Department of Cardiovascular Medicine and Hypertension, Research Field in Medicine and Health Scienc
Address	Sakuragaoka 8-35-1, Kagoshima
TEL	099-275-5318
Homepage URL
Email	iriki3@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	Department of Cardiovascular Medicine and Hypertension, Research Field in Medicine and Health Sciences, Kagoshima University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 02 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date	2014 Year 12 Month 30 Day
Date of closure to data entry	2014 Year 12 Month 30 Day
Date trial data considered complete	2015 Year 03 Month 30 Day
Date analysis concluded	2015 Year 06 Month 20 Day

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

Management information
Registered date	2015 Year 11 Month 24 Day
Last modified on	2018 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022875