Warfarin Versus Aspirin in Patients With Atrial Fibrillation and Chronic Kidney Disease

NCT ID: NCT01668901

Last Updated: 2016-10-25

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-06-30

Brief Summary

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In this study, the investigators examine whether aspirin or warfarin is useful for atrial fibrillation patients with chronic kidney disease.

Detailed Description

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randomised open labelled prospective study

We enroll patients with CHADS2 score 1 non-valvular AF with chronic kidney disease, and analyze all thromboembolic event or major bleeding event during follow-up period. Warfarin group take dose adjusted warfarin (target INR 2.0-3.0) and aspirin group take aspirin 100mg daly.

Thromboembolic events: Ischemic stroke or systemic arterial occlusion Major bleeding: gastrointestinal bleeding or intracranial bleeding (code 430, code 431, code 432 by ICD-9-CM codes)

-\> Only the first event of each case will be used for the analysis

Conditions

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Atrial Fibrillation Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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warfarin

medication

Group Type EXPERIMENTAL

warfarin

Intervention Type DRUG

anticoagulation

aspirin

medication

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

antiplatelet

Interventions

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warfarin

anticoagulation

Intervention Type DRUG

Aspirin

antiplatelet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CHADS2 score 1 nonvalvular atrial fibrillation patients with chronic kidney disease

Exclusion Criteria

* HAS-BLED ≥30
* History of syncope or seizure within 1 year
* History of major bleeding event within 6 months
* BP\>180/100
* Abnormal prothrombin time
* Hypersensitivity of aspirin or warfarin
* Folstein mini mental state examination score \<26
* Taking or had taken other anticoagulants
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seil Oh, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Seoul , Korea

Locations

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Seoul Nationap University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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WASAK

Identifier Type: -

Identifier Source: org_study_id

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