UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and efficacy of radiofrequency ablation and cryoablation in patients with atrial fibrillation (AF) under anticoagulant therapy with apixaban
Title of the study (Brief title)	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	Kenzo Hirao
Organization	Tokyo Medical and Dental University
Division name	Heart Rhythm Center
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5231
Email	0160.cvm@tmd.ac.jp

Public contact
Name of contact person	Atsuhiko Yagishita
Organization	Tokyo Medical and Dental University
Division name	Department of Advanced technology in medicine
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021873