Non-
Conditions
Interventions
The subject who treated with Japanese dose of rivaroxaban.,The subject who treated with standard dose of rivaroxaban.
Basic Science,Basic Science
Rivaroxaban Japanese dose,Rivaroxaban standard dose
Sponsors
Faculty of Medicine, Chiang Mai University
Faculty of Medicine endowment Fund
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men or women Aged ≥ 18 years 2. Patients with non-valvular AF who have been receiving rivaroxaban 3. Atrial fibrillation must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before enrolled. In addition, subjects must have medical evidence of atrial fibrillation within 1 year before and at least one day before the qualifying ECG evidence. This could be obtained from a notation in the subject's record (e.g., medical chart, hospital discharge summary). 4. Female subjects must be postmenopausal (for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, have a negative serum β-hCG pregnancy test at screening. 5. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients with severe renal impairment (CrCl<15 mL/min) 2. Cardiac-Related Conditions: Hemodynamically significant mitral valve stenosis, prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted), planned cardioversion (electrical or pharmacological), transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, PE, recent surgery, MI), known presence of atrial myxoma or left ventricular thrombus, active endocarditis 3. Hemorrhage Risk-Related Criteria: • Active internal bleeding • History of or condition associated with increased bleeding risk including, but not limited to: – Major surgical procedure or trauma within 30 days before the randomization visit – Clinically significant gastrointestinal bleeding within 6 months before the randomization visit – History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding – Chronic hemorrhagic disorder – Known intracranial neoplasm, arteriovenous malformation, or aneurysm • Planned invasive procedure with potential for uncontrolled bleeding, including major surgery • Platelet count <90,000/μL at the screening visit • Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg 4. Anemia (hemoglobin <10 g/dL) at the screening visit 5. Pregnancy or breast-feeding 6. Patients with poor compliance to medication 7. Patients who refuse to obtain informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anti-XA activity Hour 0 and Hour 3 anti-XA level | — |
Secondary
| Measure | Time frame |
|---|---|
| anti-XA normal activity Hour 0 and Hour 3 anti-XA level | — |
Countries
Thailand
Contacts
Public ContactWanwarang Wongcharoen
Faculty of Medicine, Chiang Mai University
Outcome results
None listed