Non-valvular atrial fibrillation (newly diagnosed patients
Conditions
Interventions
Xarelto Tablets (10mg or 15 mg as rivaroxaban) is continuously administered once daily after breakfast over 8 weeks (study period I). To subjects who have shown early-morning hypertension in the st
Sponsors
Jichi Medical University School of Medicine
Sogo Rinsho Medefi Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria at institutions participating in the study (1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF), or those diagnosed with non-valvular atrial fibrillation in the past and are receiving an oral anticoagulant drug (2) Patients diagnosed with hypertension, regardless of treatment with an antihypertensive drug (3) Poorly controlled patients if being treated with warfarin (4) Patients who can measure home blood pressure (5) Male or female patients at least 50 years old and less than 85 years old (6) Patients who have consented in writing
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not included in the study subjects. (1) Patients with cerebral stroke or systemic embolism that has occurred within the last 6 months (2) Patients with myocardial infarction, unstable angina, or a peripheral artery disease that has developed within the last 6 months (3) Patients with acute-phase heart failure (4) Hypertensive patients with an office systolic blood pressure of >=140mmHg even after treatment with an antihypertensive drug (5) Patients with renal failure (creatinine clearance, less than 30 mL/min) (6) Patients requiring two or more antiplatelet agents (concomitant use) (7) Patients who is using an anticoagulant drug other than dabigatran and warfarin (8) Patients requiring administration of an HIV protease inhibitor (oral drug) (9) Patients requiring administration of an azole antifungal agent (oral, or injection (except fluconazole)) (10) Patients being treated for malignant tumors (11) Patients who have undergone a surgery within the last 6 months (12) Patients with a rheumatic disease (13) Contraindicated cases of the study drugs (14) Patients who are pregnant or breast-feeding (15) Other patients that an investigator finds inappropriate to be included in the study population
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early-morning F1+2 before and after the rivaroxaban administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in factor Xa activity (%) 2) Changes in other coagulation and fibrinolysis markers: PT-INR (Prothrombin Time-International Normalized Ratio), aPTT (activated partial thromboplastin time), d-Dimer, TAT, and soluble fibrin monomer complex (SFMC) 3) Changes in cardiomyopathy markers: NT-proBNP, Troponin T 4) Occurrence/exacerbation of cerebro/cardiovascular events*1 5) Blood pressure (outpatient measurement at hospital visits), home blood pressure 6) Changes of coagulation and fibrinolysis markers in patients who underwent ablation or electrical cardioversion 7) Adverse events: Major bleeding events (ISTH criteria)*2, other bleeding events (such as GI bleeding, nasal bleeding, gingival bleeding, subcutaneous bleeding, and hematuria)*2, gastrointestinal symptoms, abnormalities in laboratory test values, etc. | — |
Countries
Japan
Contacts
Public ContactTomoyuki Kabutoya
Jichi Medical University School of Medicine Division of Cardiovascular Medicine, Department of Medicine,
Outcome results
None listed