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

February 20, 2020 updated by: Mahidol University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital, Phramongkutklao Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

80 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
90 days after initiation of OACs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
180 days after initiation of OACs
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
180 days after initiation of OACs
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
180 days after initiation of OACs
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
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
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
180 days after initiation of OACs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NOACs in Thai Octogenarians

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Primary outcome of this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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