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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01668901
Recruitment Status : Withdrawn (Financial problem)
First Posted : August 20, 2012
Last Update Posted : October 25, 2016
Information provided by (Responsible Party):
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.

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

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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

Arm Intervention/treatment
Experimental: warfarin
Drug: warfarin

Active Comparator: aspirin
Drug: Aspirin

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01668901

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Korea, Republic of
Seoul Nationap University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Seil Oh, MD,PhD Seoul National University Hospital, Seoul , Korea

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Responsible Party: Seoul National University Hospital Identifier: NCT01668901     History of Changes
Other Study ID Numbers: WASAK
First Posted: August 20, 2012    Key Record Dates
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:

Additional relevant MeSH terms:
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Atrial Fibrillation
Kidney Diseases
Renal Insufficiency, Chronic
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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