UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective,multi-center,parallel-group comparison study to evaluate safety and efficacy of dabigatran during the perioperative period in patients with non-valvular atrial fibrillation who undergo the catheter ablation compared to walfarin
Title of the study (Brief title)	Ablation perioperative dabigatran in use Envisioning in Japan(ABRIDGE-J)
Region	Japan

Condition
Condition	Non-valvular atrial fibrillation that the catheter ablation is undergone
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of dabigatran as anticoagulant therapy (4 weeks and more before operation, 3 weeks and more after operation) during the perioperative period of catheter ablation compared to walfarin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Incidence of embolism during perioperative period -Existence or non-existence of atrial thrombus just before the ablation, detected with transesophageal echocardiography or intra-cardiac Echocardiography
Key secondary outcomes	-Incidence of major bleeding and embolism during the perioperative period -Incidence of major bleeding during the perioperative period -Incidence of all bleeding during the perioperative period -Incidence of life threatening bleeding during the perioperative period -Incidence of bleeding or embolism during the perioperative period and within 6 months after operation -Number of days of hospitalization -Incidence of ischemic stroke (fatal/non-fatal),systemic embolism, pulmonary embolism,acute myocardial infarction,TIA or vascular death (including hemorrhagic death),all cause mortality and their composite endpoint -NCB(net clinical benefit)measured with the composite endpoint consisting of stroke,systemic embolism,pulmonary embolism,acute myocardial infarction,all cause mortality and major hemorrhage -All adverse event

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	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	Administration of dabigatran
Interventions/Control_2	Administration of walfarin
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 undergo the first catheter ablation for non-valvular atrial fibrillation 2_Patients with non-valvular atrial fibrillation who is being treated or will be treated with dabigatran or walfarin as anticoagulant therapy to prevent development of ischemic stroke and systemic embolism due to atrial fibrillation 3_20-85 aged patients at the time of obtaining the informed consent 4_Patients who can give the written informed consent by themselves
Key exclusion criteria	1_Patients who have a history of hypersensitivity to any ingredients of dabigatran or walfarin preparation 2_Patients who are suffering from severe renal disorder (creatinine clearance<30 mL/min) including hemodialysis patients 3_Patients who have hemorrhagic symptoms (thrombocytopenic purpura, bleeding tendency caused by vascular defect,hemophilia and other impaired blood coagulation,menstrual period,at the time of operation,gastrointestinal tract ulcer,urinary tract bleeding, hemoptysis, abortion and premature birth, puerperant associated with genital bleeding and intracranial bleeding), hemorrhagic diathesis and hemostatic disorder 4_Patients who have any organic lesion posing a clinically important risk for bleeding (including the onset of hemorrhagic stroke within the past 6 months) 5_Patients who are placing a spinal/epidural catheter 6_Patients who are receiving(oral) itraconazole 7_Patients who are pregnant and of child-bearing potential, patients who are breast-feeding or patients who want to get pregnant during the study period 8_Patients who are of bleeding potential (visceral tumor, gastrointestinal diverticulitis, colitis, subacute bacterial endocarditis, severe hypertension, severe diabetes etc.) 9_Patients who have a severe hepatic impairment 10_Patients who underwent the central nervous system operation or suffered from injury with a short history 11_Patients who are receiving vitamin K2 for osteoporosis 12_Patients who are receiving iguratimod 13_Patients who undergo an operation or bloody maneuver except the ablation 14_Patients whom the investigator judges as inappropriate subjects
Target sample size	450

Research contact person
Name of lead principal investigator	Kazutaka Aonuma
Organization	University of Tsukuba Hospital
Division name	Cardiovascular internal medicine
Address	2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL	029-853-3142
Email	tkbcar-2@md.tsukuba.ac.jp

Public contact
Name of contact person	Mizuno Harumi
Organization	Research group of anticoagulation therapy for NVAF ablation
Division name	Mebix, Inc.
Address	Akasaka Intercity 11F,
TEL	03-6229-8936
Homepage URL
Email	ablation@mebix.co.jp

Sponsor
Institute	Research group of anticoagulation therapy for NVAF ablation
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co ., Ltd
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 14 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry	2017 Year 01 Month 31 Day
Date trial data considered complete	2017 Year 02 Month 10 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 10 Day
Last modified on	2017 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015311