Atrial FibrillationNCT04062071
Use of Anticoagulant, and Associated Factors of Anticoagulant Refusal Atrial Fibrillation Patients
An observational study of Atrial Fibrillation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial summary
Atrial fibrillation is a clinically significant cardiac arrhythmia that increases the risk of stroke by 3 to 4 times. Oral anticoagulation has been shown to mitigate stroke risk by two-thirds among patients with AF and is widely recommended in optimizing AF management.Direct oral anticoagulants have also been… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Aug 2019to 23 Mar 2020
- How long will I take part?
- 2 Months
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: all of the documented atrial fibrillation patients having regular follow up in GOPC in the study period
Who may be able to join
- diagnosis as atrial fibrillation
- aged ≧18 years
- able to given consent
Who cannot join
- Unable/unwillingness to sign informed consent to study
- mechanical heart valve
- moderate-to-severe mitral stenosis
- Transient atrial fibrillation from reversible cause (e.g., during respiratory tract infection or bronchospasm)
- pregnancy
- hospitalization within 1 month prior to inclusion in the study.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
LIAO, Jiawei
Hong Kong
LIAO Jiawei, 51718217, mirachen2002@gmail.com
About this study
Official title: Prevalence of Use of Anticoagulant, and Associated Factors of Anticoagulant Refusal in Non-valvular Atrial Fibrillation Patients---- A Study in Hong Kong General Out-patient Clinic
Atrial fibrillation is a clinically significant cardiac arrhythmia that increases the risk of stroke by 3 to 4 times. Oral anticoagulation has been shown to mitigate stroke risk by two-thirds among patients with AF and is widely recommended in optimizing AF management.Direct oral anticoagulants have also been demonstrated to be superior to warfarin with respect to the risk of fatal bleeding and stroke prevention.
However, the previous study finding highlighted a great gap between current guidelines and the clinical management of AF .Nonetheless, the decision for anticoagulant use is not straightforward.It is worth to investigate the updated prevalence of anticoagulant use, the reasons for not receiving anticoagulant, and the factors independently associated with anticoagulant refusal in patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- no intervention
- Keywords
- anticoagulants
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of anticoagulant use in non-valvular atrial fibrillation patients
calculate the prevalence of anticoagulant use in non-valvular atrial fibrillation patients
Measured: August 2019 to March 2020
Secondary outcomes (1)
the rate of the refusal of anticoagulant use
calculate the rate of refusal of anticoagulant use in the eligible non-valvular atrial fibrillation patients
Measured: August 2019 to March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start23 Aug 2019 (estimated)
- Primary completion23 Mar 2020 (estimated)
- Study completion23 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chen liujing, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062071
- Sponsor's protocol ID
- version1 last update 30/7/2019
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no Conflict of interest
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Use of Anticoagulant, and Associated Factors of Anticoagulant Refusal in Non-valvular Atrial Fibrillation Patients---- A Study in Hong Kong General Out-patient Clinic
- ClinicalTrials.gov ID
- NCT04062071
- Acronym / sponsor ID
- version1 last update 30/7/2019
- Conditions
- Atrial Fibrillation
- Keywords
- anticoagulants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 23 Aug 2019 (estimated)
- Primary completion
- 23 Mar 2020 (estimated)
- Study completion
- 23 Mar 2020 (estimated)
- First posted
- 20 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.
Atrial fibrillation is a clinically significant cardiac arrhythmia that increases the risk of stroke by 3 to 4 times. Oral anticoagulation has been shown to mitigate stroke risk by two-thirds among patients with AF and is widely recommended in optimizing AF management.Direct oral anticoagulants have also been demonstrated to be superior to warfarin with respect to the risk of fatal bleeding and stroke prevention.
However, the previous study finding highlighted a great gap between current guidelines and the clinical management of AF .Nonetheless, the decision for anticoagulant use is not straightforward.It is worth to investigate the updated prevalence of anticoagulant use, the reasons for not receiving anticoagulant, and the factors independently associated with anticoagulant refusal in patients with non-valvular atrial fibrillation.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all of the documented atrial fibrillation patients having regular follow up in GOPC in the study period
Key inclusion criteria (3 listed)
- diagnosis as atrial fibrillation
- aged ≧18 years
- able to given consent
Key exclusion criteria (6 listed)
- Unable/unwillingness to sign informed consent to study
- mechanical heart valve
- moderate-to-severe mitral stenosis
- Transient atrial fibrillation from reversible cause (e.g., during respiratory tract infection or bronchospasm)
- pregnancy
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
The prevalence of anticoagulant use in non-valvular atrial fibrillation patients
Time frame: August 2019 to March 2020
calculate the prevalence of anticoagulant use in non-valvular atrial fibrillation patients
1 secondary outcome
the rate of the refusal of anticoagulant use
Time frame: August 2019 to March 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No. no Conflict of interest
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Atrial Fibrillation (AF)
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.
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 Atrial Fibrillation, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Aug 2019. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of anticoagulant use in non-valvular atrial fibrillation patients (time frame: August 2019 to March 2020). 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 20 Aug 2019.