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

This study has been withdrawn prior to enrollment.
(Financial problem)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668901
First Posted: August 20, 2012
Last Update Posted: October 25, 2016
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.
Information provided by (Responsible Party):
Seoul National University Hospital
  Purpose
In this study, the investigators examine whether aspirin or warfarin is useful for atrial fibrillation patients with chronic kidney disease.

Condition Intervention Phase
Atrial Fibrillation Chronic Kidney Disease Drug: warfarin Drug: Aspirin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

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


Secondary Outcome Measures:
  • Major bleeding [ Time Frame: through study completion, an average of 1 year ]

Enrollment: 0
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: warfarin
medication
Drug: warfarin
anticoagulation
Active Comparator: aspirin
medication
Drug: Aspirin
antiplatelet

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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 ClinicalTrials.gov identifier (NCT number): NCT01668901


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

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01668901     History of Changes
Other Study ID Numbers: WASAK
First Submitted: August 16, 2012
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