UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013341 |
|---|---|
| Receipt number | R000015566 |
| Scientific Title | Exploratory Study to Evaluate the Effect of Uninterrupted Anticoagulants in Catheter Ablation Procedure for Non-valvular Atrial Fibrillation - Comparison between Rivaroxaban and Warfarin - |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2018/09/07 14:01:01 |
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Basic information
Public title
Exploratory Study to Evaluate the Effect of Uninterrupted Anticoagulants in Catheter Ablation Procedure for Non-valvular Atrial Fibrillation
- Comparison between Rivaroxaban and Warfarin -
Acronym
A Study on Anticoagulant Therapy in Catheter Ablation for Atrial Fibrillation
- Rivaroxaban vs. Warfarin : A Comparative Study -
Scientific Title
Exploratory Study to Evaluate the Effect of Uninterrupted Anticoagulants in Catheter Ablation Procedure for Non-valvular Atrial Fibrillation
- Comparison between Rivaroxaban and Warfarin -
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Seiji Takatsuki |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-5843-6702
seiji.takatsuki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiji Takatsuki |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-5843-6702
Homepage URL
seiji.takatsuki@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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 | 12 | Month | 20 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015566
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