UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019916 |
|---|---|
| Receipt number | 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 15:13:50 |
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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
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
iriki3@m3.kufm.kagoshima-u.ac.jp
Public contact
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
iriki3@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022875
