An analysis on validity of distribution of biomarkers, exploration of correlation between biomarker outliers and adverse events under rivaroxaban in Japanese patients with non-valvular atrial fibrillation (CVI ARO 2 study)
- Conditions
- Patients with non-valvular atrial fibrillation who are taking rivaroxaban for primary prevention of ischemic stroke
- Registration Number
- JPRN-UMIN000022721
- Lead Sponsor
- The Cardiovascular Institute Academic Organization (CVI ARO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 400
Not provided
(1) Receiving dual anti-platelet therapy (2) Inadequate dosage of rivaroxaban at PT measurement (3) Rivaroxaban hypersensitivity (4) River dysfunction with clotting disorder (5) Moderate and high river dysfunction (Child-Pugh classification B or C) (6) Renal dysfunction (creatinine clearance <30 mL/min) (7) Women who are pregnant or may be pregnant (8) Patients taking HIV protease inhibitor (ritonavir, atazanavir, indinavir, etc) (9)Patients taking azole antimycotic agent (itraconazole, voriconazole, ketoconazole, etc., excluding fluconazole) (10) Patients taking drugs containing cobicistat (11) Patients taking drugs with CYP3A4 or strong P-glycoprotein derivant (rifampicin, phenytoin, carbamazepine, phenobarbital, Saint John's wort-containing food, etc.) (12) Patients with acute bacterial endocarditis (13) Patients who did not give written informed consents for this study (14) Patients who are judged by the researchers as inadequate for this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method