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

This study has been withdrawn prior to enrollment.

(Financial problem)

Sponsor:

Information provided by (Responsible Party):

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01668901

First received: August 16, 2012

Last updated: October 24, 2016

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 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 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 [ 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


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

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

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
Study First Received:	August 16, 2012
Last Updated:	October 24, 2016
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

ClinicalTrials.gov processed this record on July 24, 2017

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