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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01668901
• Other study ID #: WASAK
• Status: Withdrawn
• Phase: Phase 4
• First received: August 16, 2012
• Last updated: October 24, 2016
• Start date: September 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• warfarin
anticoagulation
• Aspirin
antiplatelet

Locations

Country	Name	City	State
Korea, Republic of	Seoul Nationap University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboembolic event	Ischemis stroke and systemic thromboembolism	through study completion, an average of 1 year	No
Secondary	Major bleeding		through study completion, an average of 1 year	No