nonvalvular atrial fibrillation (AF) AF NOAC Rivaroxaban
Conditions
Interventions
In one patient, we initiate original rivaroxaban and check for anti-factor Xa activity in the next two weeks, and then we will switch to generic rivaroxaban and compare anti-factor Xa activity between
Experimental Drug
Rivaroxaban
Sponsors
Faculty of Medicine, Chiangmai University
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Nonvalvular atrial fibrillation (NVAF: Atrial fibrillation must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before being included to study. In addition, subjects must have medical evidence of atrial fibrillation within 1 year before and at least one day before the qualifying ECG evidence. 2) Moderate to high risk for stroke 1. History of stroke, TIA or systemic embolism 2. more than 2 of the following risk factors: HF or LVEF less than 35%, HTN, age more than 75 years, diabetes
Exclusion criteria
Exclusion criteria: 1) Hemodynamically moderate-severe mitral valve stenosis 2) prosthetic heart valveatrial myxoma 3) Reversible atrial fibrillation cause or planned cardioversion 4) Current endocarditis 5) Current internal bleeding 6) history of increased bleeding risk, or planned procedure with risk of uncontrolled bleeding 7) Platelets less than 90k 8) hemoglobin less than 10 g/dL 9) Uncontrolled HTN (SBP greater than or equal to 180 mmHg or DBP greater than or equal to 100 mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-factor Xa activity 2 weeks microgram per litre/BIOPHEN DiXal kit and analyzed on a Sysmex CS 2500 System | — |
Secondary
| Measure | Time frame |
|---|---|
| event of stroke or non-central nervous system systemic 1 year Brain imaging (CT/MRI brain) | — |
Countries
Thailand
Contacts
Public ContactPongsakorn Sutinkad
Faculty of Medicine, ChiangMai University
Outcome results
None listed