Clinical trial NCT04047654: Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation
Official title: Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation : A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Atrial Fibrillation
Keywords: anticoagulant drugs
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 327
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged over 80 years with non valvular atrial fibrillation who were prescribed oral anticoagulants (OACs) which were apixaban, dabigartran, edoxaban, rivaroxaban and warfarin for stroke secondary prevention.

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.

Eligibility criteria: 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

  1. Prophylaxis thromboembolic events in valvular atrial fibrillation
  2. Treatment of venous thromboembolism
  3. Prophylaxis thromboembolic events in hip or knee replacement
* Patients who had contraindication to oral anticoagulants

  1. 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)
  2. Patients were diagnosed acute hepatitis, chronic active hepatitis

Primary outcomes:
measure: Rate recurrence of stroke or TIA in 90 days
timeFrame: 90 days after initiation of OACs
Secondary outcomes:
measure: Rate recurrence of stroke or TIA in 180 days
timeFrame: 180 days after initiation of OACs
measure: Rate of major bleeding
timeFrame: 180 days after initiation of OACs
measure: Rate of clinically relevant non-major bleeding
timeFrame: 180 days after initiation of OACs
measure: Patients's baseline characteristics associated with recurrence of stroke or TIA as assessed by multivariate cohort analysis
timeFrame: 180 days after initiation of OACs
measure: Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding as assessed by multivariate cohort analysis
timeFrame: 180 days after initiation of OACs
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Phramongkutklao Hospital
Study officials:
References: