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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019916
Receipt No. R000022875
Scientific Title Evaluation of Safety and Efficacy of Periprocedural Use of Rivaroxaban and Apixaban in Catheter Ablation for Atrial Fibrillation
Date of disclosure of the study information 2015/11/24
Last modified on 2018/03/21

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Basic information
Public title Evaluation of Safety and Efficacy of Periprocedural Use of Rivaroxaban and Apixaban in Catheter Ablation for Atrial Fibrillation
Acronym Anticoagulants in atrial fibrillation ablation
Scientific Title Evaluation of Safety and Efficacy of Periprocedural Use of Rivaroxaban and Apixaban in Catheter Ablation for Atrial Fibrillation
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Mitsuru Ohishi
Organization Kagoshima University
Division name Department of Cardiovascular Medicine and Hypertension, Research Field in Medicine and Health Sciences
Zip code
Address Sakuragaoka 8-35-1, Kagoshima
TEL 099-275-5318
Email iriki3@m3.kufm.kagoshima-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasuhisa Iriki
Organization Kagoshima University
Division name Department of Cardiovascular Medicine and Hypertension, Research Field in Medicine and Health Scienc
Zip code
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)

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
2015 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 02 Month 02 Day
Date of IRB
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

Other
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

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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