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

Primary Purpose

Atrial Fibrillation, Chronic Kidney Disease

Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
warfarin
Aspirin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring warfarin, aspirin

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul Nationap University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

warfarin

aspirin

Arm Description

medication

medication

Outcomes

Primary Outcome Measures

Thromboembolic event
Ischemis stroke and systemic thromboembolism

Secondary Outcome Measures

Major bleeding

Full Information

First Posted
August 16, 2012
Last Updated
October 24, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01668901
Brief Title
Warfarin Versus Aspirin in Patients With Atrial Fibrillation and Chronic Kidney Disease
Official Title
A Randomized Controlled Prospective Trial of Warfarin Versus Aspirin for Stroke Prevention in Patients With Atrial Fibrillation and Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Financial problem
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Chronic Kidney Disease
Keywords
warfarin, aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
warfarin
Arm Type
Experimental
Arm Description
medication
Arm Title
aspirin
Arm Type
Active Comparator
Arm Description
medication
Intervention Type
Drug
Intervention Name(s)
warfarin
Intervention Description
anticoagulation
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
antiplatelet
Primary Outcome Measure Information:
Title
Thromboembolic event
Description
Ischemis stroke and systemic thromboembolism
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Major bleeding
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seil Oh, MD,PhD
Organizational Affiliation
Seoul National University Hospital, Seoul , Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul Nationap University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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