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

This study is not yet open for participant recruitment.
Verified August 2012 by Seoul National University Hospital
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01668901
First received: August 16, 2012
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Thromboembolic event

Secondary Outcome Measures:
  • Major bleeding [ Designated as safety issue: Yes ]

Estimated Enrollment: 720
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 Drug: warfarin
Active Comparator: aspirin Drug: aspirin

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668901

Contacts
Contact: Seil Oh, MD,PhD,FHRS 82-2-2072-2088 seil@snu.ac.kr
Contact: Myung-jin Cha, MD 82-10-9070-4090 chamj81@gmail.com

Locations
Korea, Republic of
Seoul Nationap University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seil Oh, MD, PhD,FHRS     82-2-2072-2088     seil@snu.ac.kr    
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01668901     History of Changes
Other Study ID Numbers: WASAK
Study First Received: August 16, 2012
Last Updated: August 20, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
warfarin
aspirin

Additional relevant MeSH terms:
Atrial Fibrillation
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013