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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047654
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.

Condition or disease Intervention/treatment
Stroke Atrial Fibrillation Drug: Non vitamin K oral anticoagulants

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation : A Retrospective Study
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Non vitamin K oral anticoagulants (NOACs)
Patients who were prescribed with apixaban, dabigatran, edoxaban, or rivaroxaban for stroke secondary prevention.
Drug: Non vitamin K oral anticoagulants
Non vitamin K oral anticoagulants are apixaban, dabigatran, rivaroxaban, and edoxaban

Warfarin
Patients who were prescribed with warfarin for stroke secondary prevention.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047654


Locations
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Thailand
Siriraj Hospital, Phramongkutklao Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04047654     History of Changes
Other Study ID Numbers: NOACs in Thai Octogenarians
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Primary outcome of this study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
anticoagulant drugs
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants