The effect of warfarin on blood viscosity in patients with ischemic stroke
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0001291
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
• Male or female subjects with treatment-naïve non-valvular atrial fibrillation as evidenced by documented ECG evidence.
o Female subjects of childbearing potential must be abstinent or practicing methods of birth control which are recognized as effective.
o Females of childbearing potential must have a negative serum ß-hCG pregnancy test prior to study enrollment.
• Subject has a CHADS2 stroke risk score of 2 or greater and is eligible for warfarin therapy.
o Congestive heart failure, hypertension, age of 75 years or greater, and diabetes each get 1 point towards the risk score. A previous stroke, transient ischemic attack, or thromboembolism gets 2 points.
• Subject is between 18 and 90 years of age.
• Subject is willing to comply with the requirements of the study protocol.
• Subject has given written informed consent to participate in the study.
• Subject is pregnant or breast-feeding.
• Subject has transient atrial fibrillation caused by a reversible condition (i.e. thyrotoxicosis, post-surgery)
• Subject has an active infection such as endocarditis.
• Subject has active internal bleeding or history of a condition associated with increased bleeding risk.
• Subject has an anemia.
• Subject has given blood or received a blood transfusion at any point during the study.
• Subject has concurrent hyperthyroidism.
• Patient has polycythemia vera or any hyperviscosity syndrome.
• Platelet count <90,000/µL at initial screening.
• Subject has poor diabetes or hypertension control (sustained systolic blood pressure = 180 mmHg or diastolic blood pressure = 100 mmHg).
• Subject has mitral stenosis or mechanical heart valves.
• Subject is taking steroids.
• Subject has a history of severe liver disease or end-stage renal disease receiving dialysis (HD or PD) or KT.
• Family members or employees of the investigator or study centers involved in the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood viscosity levels of high (300/sec) and low (5/sec) shear rates
- Secondary Outcome Measures
Name Time Method Blood viscosity distribution according to CHADS2 scores in patients with atrial fibrillation