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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013129
Receipt No. R000015311
Scientific Title 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
Date of disclosure of the study information 2014/02/14
Last modified on 2017/07/10

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Basic information
Public title 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
Acronym Ablation perioperative dabigatran in use Envisioning in Japan(ABRIDGE-J)
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazutaka Aonuma
Organization University of Tsukuba Hospital
Division name Cardiovascular internal medicine
Zip code
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
1st name
Middle name
Last name Mizuno Harumi
Organization Research group of anticoagulation therapy for NVAF ablation
Division name Mebix, Inc.
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 14 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
2014 Year 01 Month 14 Day
Date of IRB
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

Other
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

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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