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Withdrawn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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation Chronic Kidney Disease | Drug: warfarin Drug: Aspirin | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | September 2015 |
Estimated Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: warfarin
medication
|
Drug: warfarin
anticoagulation
|
Active Comparator: aspirin
medication
|
Drug: Aspirin
antiplatelet
|
- Thromboembolic event [ Time Frame: through study completion, an average of 1 year ]Ischemis stroke and systemic thromboembolism
- Major bleeding [ Time Frame: through study completion, an average of 1 year ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668901
Korea, Republic of | |
Seoul Nationap University Hospital | |
Seoul, Korea, Republic of, 110-744 |
Principal Investigator: | Seil Oh, MD,PhD | Seoul National University Hospital, Seoul , Korea |
Responsible Party: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01668901 History of Changes |
Other Study ID Numbers: |
WASAK |
First Posted: | August 20, 2012 Key Record Dates |
Last Update Posted: | October 25, 2016 |
Last Verified: | August 2012 |
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 |