UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Study regarding the Safety of a Periprocedual Anticoagulation Regimen with Direct Oral Anticoagulant (DOAC) Other than Dabigatran in the Patients Undergoing Catheter Ablation for Paroxysmal or Persistent Atrial Fibrillation.
Acronym	SWITCH Dabigatran
Scientific Title	Prospective Study regarding the Safety of a Periprocedual Anticoagulation Regimen with Direct Oral Anticoagulant (DOAC) Other than Dabigatran in the Patients Undergoing Catheter Ablation for Paroxysmal or Persistent Atrial Fibrillation.
Scientific Title:Acronym	SWITCH Dabigatran
Region	Japan

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

Objectives
Narrative objectives1	Safety of a periprocedual anticoagulation regimen with direct oral anticoagulant (DOAC) other than dabigatran in the patients undergoing catheter ablation for paroxysmal or persistent atrial fibrillation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of major bleeding events which is defined by ISTH(International Society of Thrombosis and Hemostasis) during and up to 12 weeks after ablation
Key secondary outcomes	Following events during and up to 12 weeks after ablation ; thromboembolic events (stroke, systemic embolism) ; Minor bleeding events which were defined as clinical bleeding events that did not fulfill ISTH criteria for major bleeding events. ; a composite of major bleeding events and thromboembolic events (stroke, systemic embolism).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention period ; from the administration of dabigatran at the procedural day until 12 weeks after the ablation is performed At the time of acquiring informed consent, we confirm that anticoagulation therapy is done by one of the following drugs. ; At least three weeks before the start of ablation, the patients take Apixaban 5 mg twice a day after breakfast and dinner or 2.5 mg twice a day after breakfast and dinner. ; At least three weeks before the start of ablation, the patients take Rivaroxaban 15 mg once a day after breakfast or 10 mg once a day after breakfast. ; At least three weeks before the start of ablation, the patients take Edoxaban 60 mg once a day after breakfast or 30 mg once a day after breakfast On the day of ablation, the patients stop taking the above DOAC, take Dabigatran 110mg twice a day. Regarding ablation, we perform pulmonary vein isolation according to the method recommended by the guideline using radiofrequency catheter ablation or 28 mm cryoballoon catheter as usual, and add substrate-modification ablation to the arrhythmia as necessary.
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with paroxysmal or persistent atrial fibrillation 2) Patients taking DOAC (excluding dabigatran) at least 3 weeks before catheter ablation is performed 3) Patients scheduled for catheter ablation treatment for atrial fibrillation 4) Patients aged 20 years or older at the time of acquiring consent (no matter the sex) 5) After receiving sufficient explanation for the participation of this study, patients who got document consent by free will of the patient himself / herself
Key exclusion criteria	1) Patients with a history of hypersensitivity to components of Prazaxa capsules 2) Patients with hemorrhagic symptoms, patients with hemorrhagic diathesis and patients with hemostatic disorder 3) Patients with COPD and severe respiratory disease 4) Patients with advanced renal injury including dialysis patients (creatinine clearance less than 30 mL / min) 5) Patients with severe liver disease (AST (GOT) or ALT (GPT)> 100 U) 6) Women who may be pregnant or have a possibility of pregnancy 7) Women who are breastfeeding 8) Patients who are diagnosed as having a life expectancy of less than half a year 9) Patients who received other test drugs or investigational drugs within 3 months before the start of administration of study drug 10) Patients with organic lesions at risk of clinically serious bleeding (including hemorrhagic stroke within 6 months) 11) Patients who have indwelling spinal and epidural catheters and patients within 1 hour after removal 12) Patients receiving itraconazole (oral preparation) 13) Patients with cryoglobulinemia 14) In addition, patients who are deemed inappropriate as research subjects by research managers
Target sample size	121

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Murakami
Organization	Shonankamakura General Hospital
Division name	Department of Cardiology
Zip code	247-8533
Address	1370-1 Okamoto. kamakura Kanagawa 247-8533
TEL	0467-46-1717
Email	murakami20040408@yahoo.co.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Mizuno
Organization	Shonankamakura General Hospital
Division name	Shonankamakura General Hospital
Zip code	247-8533
Address	1370-1 Okamoto. kamakura Kanagawa 247-8533
TEL	0467-46-1717
Homepage URL
Email	radialist-children@song.ocn.ne.jp

Sponsor
Institute	Shonankamakura General Hospital Department of Cardiology
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Tokushukai Group Ethics Committee
Address	Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel	03-3263-4801
Email	mirai-ec1@mirai-iryo.com

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	医療法人　沖縄徳洲会　湘南鎌倉総合病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 07 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	Terminated
Date of protocol fixation	2017 Year 08 Month 23 Day
Date of IRB	2017 Year 12 Month 07 Day
Anticipated trial start date	2017 Year 09 Month 08 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 29 Day
Last modified on	2021 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032965