None listed
Conditions
Interventions
Drug : blood viscosity effect with warfarin vs. aspirin:
blood viscosity measurement in the group of warfarin Tx, with International Normalized Ratio (INR) 2-3
blood viscosity measurement in the group
Sponsors
Chonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood viscosity levels of high (300/sec) and low (5/sec) shear rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood viscosity distribution according to CHADS2 scores in patients with atrial fibrillation | — |
Countries
Korea, Republic of
Contacts
Public ContactKim ki
Chonbuk National University Hospital
Outcome results
None listed