Atrial Fibrillation Clinical Trial
Official title:
A Randomized Controlled Prospective Trial of Warfarin Versus Aspirin for Stroke Prevention in Patients With Atrial Fibrillation and Chronic Kidney Disease
Verified date | August 2012 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
In this study, the investigators examine whether aspirin or warfarin is useful for atrial fibrillation patients with chronic kidney disease.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2016 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul Nationap University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thromboembolic event | Ischemis stroke and systemic thromboembolism | through study completion, an average of 1 year | No |
Secondary | Major bleeding | through study completion, an average of 1 year | No |
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