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

A Randomized Controlled Prospective Trial of Warfarin Versus Aspirin for Stroke Prevention in Patients With Atrial Fibrillation and Chronic Kidney Disease

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01668901
Enrollment
0
Registered
2012-08-20
Start date
2012-09-30
Completion date
2016-06-30
Last updated
2016-10-25

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

Conditions

Atrial Fibrillation, Chronic Kidney Disease

Keywords

warfarin, aspirin

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

Interventions

DRUGwarfarin

anticoagulation

DRUGAspirin

antiplatelet

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Thromboembolic eventthrough study completion, an average of 1 yearIschemis stroke and systemic thromboembolism

Secondary

MeasureTime frame
Major bleedingthrough study completion, an average of 1 year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026