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 |
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.
SWITCH Dabigatran
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.
SWITCH Dabigatran
Japan |
paroxysmal or persistent atrial fibrillation
Cardiology |
Others
NO
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.
Safety
Confirmatory
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
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).
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
NO
NO
NO
No need to know
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
121
1st name | Masato |
Middle name | |
Last name | Murakami |
Shonankamakura General Hospital
Department of Cardiology
247-8533
1370-1 Okamoto. kamakura Kanagawa 247-8533
0467-46-1717
murakami20040408@yahoo.co.jp
1st name | Shingo |
Middle name | |
Last name | Mizuno |
Shonankamakura General Hospital
Shonankamakura General Hospital
247-8533
1370-1 Okamoto. kamakura Kanagawa 247-8533
0467-46-1717
radialist-children@song.ocn.ne.jp
Shonankamakura General Hospital
Department of Cardiology
none
Other
The Tokushukai Group Ethics Committee
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
03-3263-4801
mirai-ec1@mirai-iryo.com
NO
医療法人 沖縄徳洲会 湘南鎌倉総合病院(神奈川県)
2017 | Year | 09 | Month | 07 | Day |
Unpublished
Terminated
2017 | Year | 08 | Month | 23 | Day |
2017 | Year | 12 | Month | 07 | Day |
2017 | Year | 09 | Month | 08 | Day |
2021 | Year | 03 | Month | 31 | Day |
2017 | Year | 08 | Month | 29 | Day |
2021 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032965