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

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ClinicalTrials.gov Identifier: NCT01668901
Recruitment Status : Withdrawn (Financial problem)
First Posted : August 20, 2012
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

August 16, 2012
August 20, 2012
October 25, 2016
September 2012
September 2015   (Final data collection date for primary outcome measure)
Thromboembolic event [ Time Frame: through study completion, an average of 1 year ]
Ischemis stroke and systemic thromboembolism
Thromboembolic event
Complete list of historical versions of study NCT01668901 on ClinicalTrials.gov Archive Site
Major bleeding [ Time Frame: through study completion, an average of 1 year ]
Major bleeding
Not Provided
Not Provided
 
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
In this study, the investigators examine whether aspirin or warfarin is useful for atrial fibrillation patients with chronic kidney disease.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Chronic Kidney Disease
  • Drug: warfarin
    anticoagulation
  • Drug: Aspirin
    antiplatelet
  • Experimental: warfarin
    medication
    Intervention: Drug: warfarin
  • Active Comparator: aspirin
    medication
    Intervention: Drug: Aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
720
June 2016
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01668901
WASAK
No
Not Provided
Plan to Share IPD: No
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Seil Oh, MD,PhD Seoul National University Hospital, Seoul , Korea
Seoul National University Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP