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NCT Number: NCT04047654

Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation

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.

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Siriraj Hospital, Phramongkutklao Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non vitamin K oral anticoagulants

Drug

Non vitamin K oral anticoagulants are apixaban, dabigatran, rivaroxaban, and edoxaban

Primary outcomes

  1. 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

  1. Rate recurrence of stroke or TIA in 180 days

    Time frame: 180 days after initiation of OACs

    Rate recurrence of stroke or TIA in 180 days after initiation of OACs

  2. Rate of major bleeding

    Time frame: 180 days after initiation of OACs

    Rate of major bleeding in 90 days and 180 days after initiation of OACs

  3. Rate of clinically relevant non-major bleeding

    Time frame: 180 days after initiation of OACs

    Rate of clinically relevant non-major bleeding in 90 days and 180 days after initiation of OACs

  4. Patients's baseline characteristics associated with recurrence of stroke or TIA as assessed by multivariate cohort analysis

    Time frame: 180 days after initiation of OACs

    Patients's baseline characteristics associated with recurrence of stroke or TIA in 180 days after initiation of OACs as assessed by multivariate cohort analysis

  5. Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding as assessed by multivariate cohort analysis

    Time frame: 180 days after initiation of OACs

    Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding in 180 days as assessed by multivariate cohort analysis

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation : A Retrospective Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2019
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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