Clinical Trial for Optimal Novel Oral Anticoagulant (NOAC) Schedule Immediate Before Catheter Ablation for Atrial Fibrillation

NCT ID: NCT02504177

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-06-30

Brief Summary

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This study is to evaluated the interruption schedule of NOAC in patients who undergo atrial fibrillation ablation. The investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, Re-admission and increased in the length of hospital stay during the 30-day post-radiofrequency catheter ablation(RFCA) period among patients who interrupt NOAc 24hours before ablation and patients who stop NOAC in the morning of the procedure.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The group of keep medication NOAC

The randomization after scheduling of Ablation at clinic The explanation to stop taking medicine of NOAC 24 hours before the ablation

Group Type EXPERIMENTAL

novel oral anticoagulant for 30 days

Intervention Type DRUG

novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.

The group of stop medication NOAC 1 day

The randomization after scheduling of ablation at clinic. The explanation to stop taking medicine of NOAC day of ablation

Group Type ACTIVE_COMPARATOR

novel oral anticoagulant for 24 hour

Intervention Type DRUG

novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.

Interventions

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novel oral anticoagulant for 30 days

novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.

Intervention Type DRUG

novel oral anticoagulant for 24 hour

novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients who consent with study
2. Patients with Atrial fibrillation (20-80 years old)
3. patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation
4. Patients possible to NOAC

Exclusion Criteria

1. Patients who do not agree with study inclusion
2. eGRF \< 30ml/min
3. Impossible to NOAC
4. Structural cardiac disease
5. Major hemorrhagic complication
6. CHA2DS2-VASc score \> 5
7. Patients who have experienced Ischemic cerebellar infarction more than 2times
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Hui-Nam Pak, M.D., Ph.D.

Role: primary

82-2-2228-8459

Other Identifiers

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4-2015-0387

Identifier Type: -

Identifier Source: org_study_id

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