StrokeNCT04047654
Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation
An observational study of Stroke and Atrial Fibrillation, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation
- What is being tested?
- Non vitamin K oral anticoagulants
- Type of treatment
- Pill or oral medicine
- How many people
- 327 participants
- Where
- 1 siteThailand
- Study dates
- 22 Apr 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- Non vitamin K oral anticoagulants
- Keywords
- anticoagulant drugs
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non vitamin K oral anticoagulantsDrug
Non vitamin K oral anticoagulants are apixaban, dabigatran, rivaroxaban, and edoxaban
| Study group | Role | What they receive |
|---|---|---|
| Non vitamin K oral anticoagulants (NOACs) | Patients who were prescribed with apixaban, dabigatran, edoxaban, or rivaroxaban for stroke secondary prevention. Receives: Drug: Non vitamin K oral anticoagulants | |
| Warfarin | Patients who were prescribed with warfarin for stroke secondary prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate recurrence of stroke or TIA in 90 days
Rate recurrence of stroke or TIA in 90 days after initiation of OACs
Measured: 90 days after initiation of OACs
Secondary outcomes (5)
Rate recurrence of stroke or TIA in 180 days
Rate recurrence of stroke or TIA in 180 days after initiation of OACs
Measured: 180 days after initiation of OACs
Rate of major bleeding
Rate of major bleeding in 90 days and 180 days after initiation of OACs
Measured: 180 days after initiation of OACs
Rate of clinically relevant non-major bleeding
Rate of clinically relevant non-major bleeding in 90 days and 180 days after initiation of OACs
Measured: 180 days after initiation of OACs
Patients's baseline characteristics associated with recurrence of stroke or TIA as assessed by multivariate cohort analysis
Patients's baseline characteristics associated with recurrence of stroke or TIA in 180 days after initiation of OACs as assessed by multivariate cohort analysis
Measured: 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
Patients's baseline characteristics associated with major bleeding and clinically relevant non-major bleeding in 180 days as assessed by multivariate cohort analysis
Measured: 180 days after initiation of OACs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start22 Apr 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047654
- Sponsor's protocol ID
- NOACs in Thai Octogenarians
- Status last verified
- Feb 2020
- First submitted
- 25 Jul 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Primary outcome of this study
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Anticoagulants Among Thai Octogenarians With Nonvalvular Atrial Fibrillation : A Retrospective Study
- ClinicalTrials.gov ID
- NCT04047654
- Acronym / sponsor ID
- NOACs in Thai Octogenarians
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- anticoagulant drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non vitamin K oral anticoagulants (NOACs) | – | Drug: Non vitamin K oral anticoagulantsPatients who were prescribed with apixaban, dabigatran, edoxaban, or rivaroxaban for stroke secondary prevention. |
| Warfarin | – | –Patients who were prescribed with warfarin for stroke secondary prevention. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Patients were prescribed oral anticoagulants for other indications
- Patients who had contraindication to oral anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non vitamin K oral anticoagulantsNon vitamin K oral anticoagulants are apixaban, dabigatran, rivaroxaban, and edoxaban | Drug | Non vitamin K oral anticoagulants (NOACs) |
Primary outcome
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
5 secondary outcomes
Rate recurrence of stroke or TIA in 180 days
Time frame: 180 days after initiation of OACs
Rate of major bleeding
Time frame: 180 days after initiation of OACs
Rate of clinically relevant non-major bleeding
Time frame: 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 major bleeding and clinically relevant non-major bleeding as assessed by multivariate cohort analysis
Time frame: 180 days after initiation of OACs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: Undecided. Primary outcome of this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Atrial Fibrillation, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate recurrence of stroke or TIA in 90 days (time frame: 90 days after initiation of OACs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.