UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013129 |
|---|---|
| Receipt number | 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 11:01:57 |
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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
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
ablation@mebix.co.jp
Sponsor or person
Institute
Research group of anticoagulation therapy for NVAF ablation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015311
