1. Patients diagnosed with nonvalvular atrial fibrillation (NVAF) who require oral anticoagulant therapy 2. Patients diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) who have been treated with oral or parenteral anticoagulant therapy for at least 7 days Nonvalvular atrial fibrillation, deep vein thrombosis, pulmonary embolism, anticoagulant, apixaban, factor Xa inhibitor, anti-factor Xa activity
Conditions
Interventions
During Days 15 to 28 of the Phase 1 study, patients taking original apixaban will be assigned to switch to generic apixaban, while those taking generic apixaban will be switched to the original formul
Experimental Drug,Active Comparator Drug
Generic apixaban,Original apixaban
Sponsors
Atlanta Medicare Company Limited
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 20 years old 2. Patients diagnosed with nonvalvular atrial fibrillation (NVAF) who require oral anticoagulant therapy must have atrial fibrillation confirmed by electrocardiogram (ECG) evidence, such as a 12-lead ECG, rhythm strip, or Holter monitor. 3. Patients diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) who have been treated with oral or parenteral anticoagulant therapy for at least 7 days must have their diagnosis confirmed by previous imaging, such as duplex Doppler ultrasound, computed tomography (CT) angiogram, or chest CT.
Exclusion criteria
Exclusion criteria: 1. Hemodynamically moderate or severe mitral valve stenosis 2. Prosthetic heart valve(s) 3. Atrial myxoma 4. Planned cardioversion or ablation 5. Active endocarditis 6. Active internal bleeding or increased bleeding risk 7. Platelet count less than 90,000 microL or hemoglobin less than 10 g/dL 8. Uncontrolled hypertension (SBP greater than or equal to 180 mmHg or DBP greater than or equal to 100 mmHg) 9. Stroke less than 14 days or TIA less than 3 days 10. Treatment with fibrinolytics in prior 10 days 11. CrCl less than 15 mL/min or renal replacement therapy (hemodialysis or peritoneal dialysis) 12. Significant liver disease or ALT greater than 3 times the upper normal limit 13. Pregnancy, planning to become pregnant, or breastfeeding 14. Need for chronic use of CYP3A4/5 strong inducer or inhibitor 15. Short life expectancy (less than 1 year or active cancer) 16. Allergy to apixaban
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak and Trough Anti-Factor Xa level Day 14 and day 28 Using the BIOPHEN DiXal kit (chromogenic anti-FXa; Dasit, Milan, Italy) and analyzed on a Sysmex CS 2500 System (Siemens Health Care, Milan, Italy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Ischemic stroke or systemic embolism Day 14, day 28, month 4, and month 7 Physician diagnosis with computed tomography (CT) angiogram,Recurrent venous thromboembolism included fatal or non-fatal pulmonary embolism and deep vein thrombosis Day 14, day 28, month 4, and month 7 Diagnosis confirmed by duplex Doppler ultrasound, computed tomography (CT) angiogram, or chest CT,The occurrence of clinically relevant bleeding (Bleeding Academic Research Consortium (BARC) types 2, 3, 5) Day 14, day 28, month 4, and month 7 Bleeding Academic Research Consortium (BARC) criteria | — |
Countries
Thailand
Contacts
Public ContactKrit Leemasawat
Faculty of Medicine, Chiang Mai University
Outcome results
None listed