Skip to content

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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028892
Enrollment
121
Registered
2017-09-07
Start date
2017-09-08
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paroxysmal or persistent atrial fibrillation

Interventions

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
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 t

Sponsors

Shonankamakura General Hospital Department of Cardiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria:

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactShingo Mizuno

Shonankamakura General Hospital Shonankamakura General Hospital

radialist-children@song.ocn.ne.jp0467-46-1717

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026