An analysis on distribution of biomarkers and soluble fibrin monomer complex (SFMC) at trough under direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation patients with CHA2DS2-VASc score greater than 2 (CVI ARO 13)
- Conditions
- Atrial fibrillation
- Registration Number
- JPRN-UMIN000051183
- Lead Sponsor
- The Cardiovascular Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
Patients with any of the following at the enrollment were excluded; (1) receiving antiplatelet therapy, (2) inadequate dosage of FXaI with the Japanese pharmaceutical reference; (3) FXaI hypersensitivity; (4) patients with active bleeding (intracranial hemorrhage or retroperitoneal hemorrhage or bleeding in other important organs); (5) patients with acute bacterial endocarditis; (6) renal dysfunction (creatinine clearance < 30 mL/min); (7) liver dysfunction with clotting disorder; (8) cardiovascular event (stroke, myocardial infarction, percutaneous coronary intervention, and admission with heart failure) or major bleeding with admission before one month of enrollment, (9) patients who did not provide written informed consent; and (10) patients who were judged by the researchers to be inappropriate for this study (i.e., incapable of understanding the study protocol due to dementia, intellectual disturbance, and/or psychiatric/psychosomatic disorder).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method