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

Phase 4
Withdrawn
Conditions
Atrial Fibrillation
Chronic Kidney Disease
Interventions
Registration Number
NCT01668901
Lead Sponsor
Seoul National University Hospital
Brief Summary

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

Detailed Description

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

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
warfarinwarfarinmedication
aspirinAspirinmedication
Primary Outcome Measures
NameTimeMethod
Thromboembolic eventthrough study completion, an average of 1 year

Ischemis stroke and systemic thromboembolism

Secondary Outcome Measures
NameTimeMethod
Major bleedingthrough study completion, an average of 1 year

Trial Locations

Locations (1)

Seoul Nationap University Hospital

🇰🇷

Seoul, Korea, Republic of

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