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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018901
Receipt No. R000021873
Scientific Title The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban
Date of disclosure of the study information 2015/09/03
Last modified on 2017/09/29

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Basic information
Public title The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban
Acronym The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban(J-HIT Study)
Scientific Title The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban
Scientific Title:Acronym The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban(J-HIT Study)
Region
Japan

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

Objectives
Narrative objectives1 Comparing radiofrequency ablation and cryoablation in patients with AF taking apixaban, and demonstrate the safety and efficacy of both therapies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite of major bleedings and thromboembolism during perioperative period and within 4 weeks after the surgery.
Key secondary outcomes Recurrence of AF during the follow-up period (because the presence or absence of recurrence may be associated with the development of embolic events), non-major bleeding, pericardial effusions not requiring drainage.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Apixaban_radiofrequency ablation
Interventions/Control_2 Apixaban_cryoablation
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients who are indicated for catheter ablation for drug-resistant non-valvular paroxysmal AF in the Japanese Heart Rhythm Society Guidelines
2)Patients who undergo the first catheter ablation while taking apixaban
3)Patients of age between 20 and 85 years
4)Patients for whom consent for participation in this study have been obtained in writing
Key exclusion criteria Patients with a history of hypersensitivity to the components of apixaban.
Patients with clinically significant bleeding symptoms.
Patients with blood clotting defect and liver disease at clinically significant bleeding risk.
Target sample size 260

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenzo Hirao
Organization Tokyo Medical and Dental University
Division name Heart Rhythm Center
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5231
Email 0160.cvm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuhiko Yagishita
Organization Tokyo Medical and Dental University
Division name Department of Advanced technology in medicine
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5231
Homepage URL
Email atsuhikoyagishita.cvm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
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 さいたま赤十字病院(埼玉県)、土浦協同病院(茨城県)、横須賀共済病院(神奈川県)、武蔵野赤十字病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 03 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 No longer recruiting
Date of protocol fixation
2015 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 03 Day
Last modified on
2017 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021873

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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