UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028892 |
|---|---|
| Receipt number | R000032965 |
| 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. |
| Date of disclosure of the study information | 2017/09/07 |
| Last modified on | 2021/10/11 13:32:41 |
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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
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
radialist-children@song.ocn.ne.jp
Sponsor or person
Institute
Shonankamakura General Hospital
Department of Cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032965
