Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation : A Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 327
- Locations
- 1
- Primary Endpoint
- Rate recurrence of stroke or TIA in 90 days
Study Overview
Brief Summary
A retrospective cohort study of Thai octogenarians with nonvalvular atrial fibrillation (NVAF) initiating apixaban, dabigatran, rivaroxaban or warfarin was conducted in medical school hospital in Thailand. Patients were recruited from January 1, 2013, to December 31, 2018. The efficacy outcome was early recurrence of stroke or transient ischemic attack (TIA) in 90 days after initiation of oral anticoagulants (OACs). The safety outcome were major bleeding and clinically relevant non-major bleeding complications in 180 days. Continuous variables were compared using independent t test and MannWhitney U test, and categorical variables were compared using chi-square test or Fisher's exact test. Furthermore, hazard ratios and P values were calculated by the use of multivariable Cox's regression analysis.
Detailed Description
This is a retrospective cohort study of Thai octogenarians with NVAF. Patients who were prescribed with apixaban, dabigatran, edoxaban, rivaroxaban or warfarin from January 1, 2013, to December 31, 2018 were recruited. The primary efficacy was recurrent ischemic stroke or TIA in 90 days after initiating OACs. The secondary efficacy were recurrent ischemic stroke or TIA in 180 days after initiating OACs. While any bleeding complications were defied as primary safety outcomes. Continuous variables were compared using independent t test and MannWhitney U test, and categorical variables were compared using chi-square test or Fisher's exact test.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 80 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age more than 80 years old
- •Patients who were diagnosed with I48, I63 or G45 from International Classification of Diseases 10th version (ICD-10). Patients who were diagnosed atrial fibrillation and flutter, cerebral infarction or transient cerebral ischemic attacks (TIA) and related syndromes)
- •Patients were prescribed apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin
Exclusion Criteria
- •Patients were prescribed oral anticoagulants for other indications
- •Prophylaxis thromboembolic events in valvular atrial fibrillation
- •Treatment of venous thromboembolism
- •Prophylaxis thromboembolic events in hip or knee replacement
- •Patients who had contraindication to oral anticoagulants
- •Creatinine clearance calculated from Cockcroft-Gault equation 1.1 Creatinine clearance less than 30 mL/min (for patients who receiving Dabigatran) 1.2 Creatinine clearance less than 15 (mL/min (for patients who receiving Apixaban, Edoxaban, Rivaroxaban)
- •Patients were diagnosed acute hepatitis, chronic active hepatitis
Arms & Interventions
Non vitamin K oral anticoagulants (NOACs)
Patients who were prescribed with apixaban, dabigatran, edoxaban, or rivaroxaban for stroke secondary prevention.
Intervention: Non vitamin K oral anticoagulants (Drug)
Outcomes
Primary Outcomes
Rate recurrence of stroke or TIA in 90 days
Time Frame: 90 days after initiation of OACs
Rate recurrence of stroke or TIA in 90 days after initiation of OACs
Secondary Outcomes
- Rate of major bleeding(180 days after initiation of OACs)
- Rate of clinically relevant non-major bleeding(180 days after initiation of OACs)
- Rate recurrence of stroke or TIA in 180 days(180 days after initiation of OACs)
- Patients's baseline characteristics associated with recurrence of stroke or TIA as assessed by multivariate cohort analysis(180 days after initiation of OACs)
- Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding as assessed by multivariate cohort analysis(180 days after initiation of OACs)