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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Chronic Kidney Disease	Drug: warfarin; Drug: Aspirin	Phase 4

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Randomized Controlled Prospective Trial of Warfarin Versus Aspirin for Stroke Prevention in Patients With Atrial Fibrillation and Chronic Kidney Disease
Study Start Date :	September 2012
Estimated Primary Completion Date :	September 2015
Estimated Study Completion Date :	June 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: warfarin; medication	Drug: warfarin; anticoagulation
Active Comparator: aspirin; medication	Drug: Aspirin; antiplatelet

Outcome Measures

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Primary Outcome Measures :

1. Thromboembolic event [ Time Frame: through study completion, an average of 1 year ]
   Ischemis stroke and systemic thromboembolism

Secondary Outcome Measures :

1. Major bleeding [ Time Frame: through study completion, an average of 1 year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Korea, Republic of
Seoul Nationap University Hospital
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:	Seil Oh, MD,PhD	Seoul National University Hospital, Seoul , Korea

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01668901 History of Changes
Other Study ID Numbers:	WASAK
First Posted:	August 20, 2012
Last Update Posted:	October 25, 2016
Last Verified:	August 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Seoul National University Hospital:

warfarin; aspirin

Additional relevant MeSH terms:

Atrial Fibrillation; Kidney Diseases; Renal Insufficiency, Chronic; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Urologic Diseases; Renal Insufficiency; Aspirin; Warfarin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics	Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Anticoagulants