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

Seoul National University

Status and phase: Withdrawn; Phase 4

Conditions: Chronic Kidney Disease; Atrial Fibrillation

Treatments: Drug: Aspirin; Drug: warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT01668901

WASAK

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

warfarin

Experimental group

Description:

medication

Treatment:

Drug: warfarin

aspirin

Active Comparator group

Description:

medication

Treatment:

Drug: Aspirin