Atrial fibrillation apixaban atrial fibrillation pharmacogenetics bleeding genetic polymorphism anti-FXa CYP3A5 ABCB1 ABCG2
Conditions
Interventions
Patients who experienced major bleeding or clinically relevant non-major bleeding (CRNMB) during apixaban therapy. Bleeding events are confirmed by ICD-10 codes related to hemorrhagic disorders due to
Treatment,Treatment
Sponsors
Krit wattanathum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Thai patients aged 18 years or older, 2.Confirmed diagnosis of atrial fibrillation (ICD-10: I48.0, I48.1, I48.2, or I48.9), 3. Received continuous apixaban therapy for at least two weeks, 4. Treated at King Chulalongkorn Memorial Hospital, Thai Red Cross Society during 2016 to 2026, 5. Voluntarily agreed to undergo blood sampling for genotyping
Exclusion criteria
Exclusion criteria: 1. Concurrent use of other anticoagulants, 2. Coagulation disorders including Hemophilia A, Hemophilia B, or von Willebrand disease, 3. Thrombocytopenia with platelet count below 90,000 cells per microliter, immune thrombocytopenia, or thrombocytopenia secondary to hemotherapy with bone marrow suppression, 4.Postoperative bleeding within 14 days of surgery, 5.Inability or unwillingness to provide informed consent or to undergo blood sampling, 6. End-stage renal disease requiring dialysis, 7. Active cancer defined as a diagnosis of cancer within the previous 6 months, ongoing cancer treatment including chemotherapy, radiotherapy, targeted therapy, or immunotherapy, metastatic disease, or recurrent or progressive malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite CRNMB/Major bleeding Assessed at the index date, defined as the date of the first confirmed bleeding event after apixaban initiation for cases, and the corresponding matched case's index date for controls. Electronic medical record (EMR) review using ICD-10 codes, confirmed by detailed chart review, and classified according to ISTH criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| anti-FXa activity At the closest available measurement to the index date as documented in the medical record. Anti-FXa activity retrieved from EMR, measured by chromogenic assay at King Chulalongkorn Memorial Hospital | — |
Countries
Thailand
Contacts
Public Contactkrit wattanathum
Faculty of Pharmaceutical Sciences Chulalongkorn University
Outcome results
None listed