Atrial FibrillationNCT03310801
LAAO With DAPT Versus Antithrombotic Therapy
An observational study of Atrial Fibrillation and Coronary Artery Disease, run by Korea University Anam Hospital.
Trial summary
This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- ACP or Watchman
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 30 Aug 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with AF who underwent PCI
Who may be able to join
- patients with AF who underwent PCI and treated with LAAO and DAPT or conventional antithrombotic therapy
Who cannot join
- -
About this study
Official title: Comparison of Clinical Outcomes Between Left Atrial Appendage Occlusion With Dual Antiplatelet Therapy Versus Conventional Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-eluting Stent Implantation
This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.
Read the detailed description
Composite of stroke and major bleeding will be compared after adjusting those groups using inverse probability weighted model.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Being tested
- ACP or Watchman
- Keywords
- left atrial appendage occlusion, antithrombotic therapy, atrial fibrillation, percutaneous coronary intervention, drug eluting stent
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP or WatchmanProcedure or surgery
Left atrial appnedage occlusion using ACP or Watchman
| Study group | Role | What they receive |
|---|---|---|
| LAAO with DAPT | patients with AF who underwent PCI and treated with LAAO(either ACP or Watchman) and DAPT Receives: Procedure: ACP or Watchman | |
| Conventional antithrombotic therapy | patients with AF who underwent PCI and treated with conventional antithrombotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of stroke and major bleeding
Primary endpoint is a composite of stroke and major bleeding. Stroke is defined as ischemic cerebrovascular event included both transient ischemic attack and ischemic cerebral infarction. Major bleeding event was defined as moderate or severe bleeding according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria.
Measured: From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Aug 2016
- Primary completion1 Aug 2017
- Study completion30 Aug 2017
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Sejong General Hospital, Gachon University Gil Medical Center, Ulsan University Hospital
- Responsible party
- Principal investigator, Dr. Cheol Woong Yu, Korea University Anam Hospital
- Investigators
- Cheol Woong Yu, MD, PhD, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310801
- Sponsor's protocol ID
- LAAO with DAPT
- Status last verified
- Oct 2017
- First submitted
- 17 Sep 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes Between Left Atrial Appendage Occlusion With Dual Antiplatelet Therapy Versus Conventional Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT03310801
- Acronym / sponsor ID
- LAAO with DAPT
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Keywords
- left atrial appendage occlusion, antithrombotic therapy, atrial fibrillation, percutaneous coronary intervention, drug eluting stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Severance Hospital, Sejong General Hospital, Gachon University Gil Medical Center, Ulsan University Hospital
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 16 Oct 2017 (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.
This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.
Detailed description
Composite of stroke and major bleeding will be compared after adjusting those groups using inverse probability weighted model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAAO with DAPT | – | Procedure: ACP or Watchmanpatients with AF who underwent PCI and treated with LAAO(either ACP or Watchman) and DAPT |
| Conventional antithrombotic therapy | – | –patients with AF who underwent PCI and treated with conventional antithrombotic therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with AF who underwent PCI
Key inclusion criteria (1 listed)
- patients with AF who underwent PCI and treated with LAAO and DAPT or conventional antithrombotic therapy
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ACP or WatchmanLeft atrial appnedage occlusion using ACP or Watchman | Procedure or surgery | LAAO with DAPT |
Primary outcome
Composite of stroke and major bleeding
Time frame: From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months
Primary endpoint is a composite of stroke and major bleeding. Stroke is defined as ischemic cerebrovascular event included both transient ischemic attack and ischemic cerebral infarction. Major bleeding event was defined as moderate or severe bleeding according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria.
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 16 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Cheol Woong Yu, MD, PhD principal investigator
Korea University Anam Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Coronary Artery Disease, run by Korea University Anam Hospital.
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 1 inclusion and 1 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 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Composite of stroke and major bleeding (time frame: From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months). 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 16 Oct 2017; AzTrials last refreshed its copy on 28 Oct 2026.