Atrial FibrillationNCT03108872
Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Sejong General Hospital at 1 site in South Korea.
Trial summary
We will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- left atrial appendage occlusion and New oral anticoagulants
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 May 2017to 30 Oct 2017
- How long will I take part?
- 4 Years
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atrial fibrillation with high risk of ischemic stroke or systemic embolism
Who may be able to join
- Patients with atrial fibrillation, who LAAO or NOAC to prevent ischemic stroke or systemic embolism
- Patients with CHA2DS2-VASc score >1
Who cannot join
- Patients who failed to successfully implant LAAO
- Patients who receive new oral anticoagulant less than 6 months without clinical events
- Patients with mitral stenosis more than mild grade
- Patients with prosthetic heart valve
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sejong general hospital, 91-121 Sosa 2-Dong, Sosa-Gu
Bucheon-si, Gyeonggi-do, 422-711
Hyun-Jong Lee, MD, 82-10-6217-9315, untouchables@sejongh.co.kr
About this study
Official title: Long Term Clinical Outcomes of Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation; From Korean Multicenter Registry
We will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data
Read the detailed description
Atrial fibrillation (AF) is associated with a substantial risk of stroke and systemic embolism. Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation and high risk of ischemic stroke. However, their use is limited by a narrow therapeutic range, increased risk of intracranial hemorrhage, the need for continuous monitoring of INR, and drug or food interaction. New oral anticoagulants (NOACs), the direct thrombin inhibitor and the factor Xa inhibitor, have settled these limitations of warfarin therapy. In four pivotal phase 3 clinical trials and their meta-analysis, NOACs have been shown to significantly reduce ischemic stroke, intracranial hemorrhage, and mortality, and had similar major bleeding as for warfarin in patients with non-valvular atrial fibrillation (NVAF). Another new treatment strategy for prevention of stroke is left atrial appendage occlusion (LAAO). Left atrial appendage has been considered to be an origin of thrombi more than 90% of cases. The concept that exclusion of LAA from the circulation reduces the risk of stroke in patients with NVAF is therefore being tested in clinical studies. LAAO with Watchman device and only aspirin were proved to be non-inferior to warfarin for ischemic stroke prevention or systemic embolism. And, LAAO reduced significantly cardiac death and hemorrhagic stroke compared to warfarin in a long-term follow up. Up to date, there was no study to compare long-term clinical outcomes between LAAO and NOACs, which are two new treatment strategies for stroke prevention in patients with NVAF.
- Conditions
- Atrial Fibrillation
- Being tested
- left atrial appendage occlusion, New oral anticoagulants
- Keywords
- Anticoagulants, Atrial Appendage, Stroke
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left atrial appendage occlusionDevice
Percutaneous exclusion of left atrial appendage with Watchman or ACP devices
New oral anticoagulantsDrug
Include dabigatran, rivaroxaban, apixaban and edoxaban
| Study group | Role | What they receive |
|---|---|---|
| LAAO group | One-hundred consecutive patients who underwent left atrial appendage occlusion from October 2010 to March 2015 in 5 Korean tertiary cardiovascular centers will be retrospectively registered. Receives: Device: left atrial appendage occlusion | |
| NOAC group | Two-hundred age-, sex-, CHA2DS2-VASc score- and HAS-BLED score- matched control will be selected with a 1:2 ratio among all patients treated with new oral anticoagulants to prevent ischemic events from 5 centers during same periods Receives: Drug: New oral anticoagulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary effectiveness endpoint
The composite of cardiovascular or unexplained death, or ischemic stroke, or systemic embolism
Measured: During 4 years
Primary safety endpoint
Major bleeding or Serious device-related complications
Measured: During 4 years
Secondary outcomes (5)
Cardiovascular or unexplained death
Measured: During 4 years
Ischemic stroke or systemic embolism
Measured: During 4 years
Hemorrhagic stroke
Measured: During 4 years
Major bleeding
Bleeding event that required at least 2 units of packed RBCs or Symptomatic bleeding in a critical area or organ.
Measured: During 4 years
Serious device-related complications
Serious pericardial effusion need procedure or surgery, peri-procedural stroke, or device embolization
Measured: During 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start23 May 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion30 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Sejong General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Anam Hospital, Yonsei University, Gachon University Gil Medical Center, Ulsan University Hospital
- Responsible party
- Principal investigator, Hyun Jong Lee, Sejong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108872
- Sponsor's protocol ID
- Ver 1.0_20170306
- Status last verified
- May 2017
- First submitted
- 6 Apr 2017
- Last updated
- 24 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kim JS, Lee H, Suh Y, Pak HN, Hong GR, Shim CY, Yu CW, Lee HJ, Kang WC, Shin ES, Choi RK, Kar S, Park JW, Lim DS, Jang Y. Left Atrial Appendage Occlusion in Non-Valvular Atrial Fibrillation in a Korean Multi-Center Registry. Circ J. 2016 Apr 25;80(5):1123-30. doi: 10.1253/circj.CJ-15-1134. Epub 2016 Mar 17.
PubMed 26984716
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical Outcomes of Left Atrial Appendage Occlusion Versus New Oral Anticoagulants for Stroke Prevention in Patients With Non-valvular Atrial Fibrillation; From Korean Multicenter Registry
- ClinicalTrials.gov ID
- NCT03108872
- Acronym / sponsor ID
- Ver 1.0_20170306
- Conditions
- Atrial Fibrillation
- Keywords
- Anticoagulants, Atrial Appendage, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sejong General HospitalUniversity, hospital or other
- Collaborators
- Korea University Anam Hospital, Yonsei University, Gachon University Gil Medical Center, Ulsan University Hospital
- Study start
- 23 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 30 Oct 2017 (estimated)
- First posted
- 11 Apr 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.
We will compare long-term effectiveness and safety in patients with atrial fibrillation treated with left atrial appendage occlusion versus new oral anticoagulants to prevent ischemic stroke from multicenter registry data
Detailed description
Atrial fibrillation (AF) is associated with a substantial risk of stroke and systemic embolism. Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation and high risk of ischemic stroke. However, their use is limited by a narrow therapeutic range, increased risk of intracranial hemorrhage, the need for continuous monitoring of INR, and drug or food interaction. New oral anticoagulants (NOACs), the direct thrombin inhibitor and the factor Xa inhibitor, have settled these limitations of warfarin therapy. In four pivotal phase 3 clinical trials and their meta-analysis, NOACs have been shown to significantly reduce ischemic stroke, intracranial hemorrhage, and mortality, and had similar major bleeding as for warfarin in patients with non-valvular atrial fibrillation (NVAF). Another new treatment strategy for prevention of stroke is left atrial appendage occlusion (LAAO). Left atrial appendage has been considered to be an origin of thrombi more than 90% of cases. The concept that exclusion of LAA from the circulation reduces the risk of stroke in patients with NVAF is therefore being tested in clinical studies. LAAO with Watchman device and only aspirin were proved to be non-inferior to warfarin for ischemic stroke prevention or systemic embolism. And, LAAO reduced significantly cardiac death and hemorrhagic stroke compared to warfarin in a long-term follow up. Up to date, there was no study to compare long-term clinical outcomes between LAAO and NOACs, which are two new treatment strategies for stroke prevention in patients with NVAF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAAO group | – | Device: left atrial appendage occlusionOne-hundred consecutive patients who underwent left atrial appendage occlusion from October 2010 to March 2015 in 5 Korean tertiary cardiovascular centers will be retrospectively registered. |
| NOAC group | – | Drug: New oral anticoagulantsTwo-hundred age-, sex-, CHA2DS2-VASc score- and HAS-BLED score- matched control will be selected with a 1:2 ratio among all patients treated with new oral anticoagulants to prevent ischemic events from 5 centers during same periods |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atrial fibrillation with high risk of ischemic stroke or systemic embolism
Key inclusion criteria (2 listed)
- Patients with atrial fibrillation, who LAAO or NOAC to prevent ischemic stroke or systemic embolism
- Patients with CHA2DS2-VASc score >1
Key exclusion criteria (4 listed)
- Patients who failed to successfully implant LAAO
- Patients who receive new oral anticoagulant less than 6 months without clinical events
- Patients with mitral stenosis more than mild grade
- Patients with prosthetic heart valve
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 |
|---|---|---|
| left atrial appendage occlusionPercutaneous exclusion of left atrial appendage with Watchman or ACP devices | Device | LAAO group |
| New oral anticoagulantsInclude dabigatran, rivaroxaban, apixaban and edoxaban | Drug | NOAC group |
Primary outcome
Primary effectiveness endpoint
Time frame: During 4 years
The composite of cardiovascular or unexplained death, or ischemic stroke, or systemic embolism
Primary safety endpoint
Time frame: During 4 years
Major bleeding or Serious device-related complications
5 secondary outcomes
Cardiovascular or unexplained death
Time frame: During 4 years
Ischemic stroke or systemic embolism
Time frame: During 4 years
Hemorrhagic stroke
Time frame: During 4 years
Major bleeding
Time frame: During 4 years
Serious device-related complications
Time frame: During 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Background: PubMed 26984716Kim JS, Lee H, Suh Y, Pak HN, Hong GR, Shim CY, Yu CW, Lee HJ, Kang WC, Shin ES, Choi RK, Kar S, Park JW, Lim DS, Jang Y. Left Atrial Appendage Occlusion in Non-Valvular Atrial Fibrillation in a Korean Multi-Center Registry. Circ J. 2016 Apr 25;80(5):1123-30. doi: 10.1253/circj.CJ-15-1134. Epub 2016 Mar 17.
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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.
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 Sejong General Hospital at 1 site in South Korea.
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 2 inclusion and 4 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 24 May 2017. 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 South Korea. 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?
Contact Hyun Jong Lee, MD (82-10-6217-9315, untouchables@sejongh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary effectiveness endpoint (time frame: During 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108872, which also lists 1 linked publication.
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 24 May 2017.