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

This study is not yet open for participant recruitment. (see Contacts and Locations)

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:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Blood Thinners Chronic Kidney Disease Kidney Diseases

Drug Information available for: Aspirin Warfarin Warfarin sodium

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

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, see Learn About Clinical Studies.

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 Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Renal Insufficiency Urologic Diseases Aspirin Warfarin Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal	Anticoagulants Antipyretics Antirheumatic Agents Cardiovascular Agents Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 27, 2015

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