Atrial FibrillationPhase 4NCT02606552

Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-Eluting Stent Implantation Due to Complex Coronary Artery Disease

A Phase 4 study testing Dabigatrain plus aspirin, Dabigatrain plus clopidogrel and Amplazter Cardiac Plug (ACP) in people with Atrial Fibrillation and Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Comparatively analyze the safety and validity of Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure, and the medical treatment with dabigatran plus aspirin or dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy)) in patient with… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Atrial Fibrillation, Coronary Artery Disease
What is being tested?: Dabigatrain plus aspirin, Dabigatrain plus clopidogrel and Amplazter Cardiac Plug (ACP)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteSouth Korea
Study dates: 20 Jul 2016to 23 Jun 2017
Phase: Phase 4
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients older than 20 years accompanying chronic atrial fibrillation with CHADS2 score ≥2
Patients with coronary artery disease (which requires DES) should receive the 2nd generation drug-eluting stent insertion treatment
Subjects and their legal representatives must understand the main purpose of this study, agree with relevant provisions, and sign to consent forms approved by IRBs of each institution.
Subjects should agree with the follow-up studies as (coronary angiography) and transesophageal echocardiography, etc.
Subjects should agree to follow our requests for post-operative follow-up visits.

Who cannot join

Patients showing any hypersensitive reaction or reason for restriction to aspirin, heparin, clopidogrel, or warfarin, or otherwise, susceptible to contrast media, and therefore, who could not use those drugs and who were pregnant or breast feeding.
Comorbidities other than atrial fibrillation that required chronic warfarin use.
Patients diagnosed with progressive infection condition or endocarditis.
Patients who have been diagnosed with progressive gastric ulcer or upper gastrointestinal bleeding for last 3 months.
Hemodynamically unstable patients who needs inotropic supports.
Senile dementia patients who have experienced any cerebrovascular accident (CVA) for last 6 weeks.

Show all 15Show fewer

Patients who have been diagnosed with intracardiac mass, thrombus, or vegetation as echocardiographic findings.
Patients diagnosed with severe left ventricular dysfunction (<LVEF 30%).
Patients with blood disorder as followings: leucopenia (<WBC 3,000mm3), acute anemia (<Hg 9mg %), Thrombocytopenia (<100,000 platelets/mm3), or any evidence of bleeding or clotting disorders.
Patients showing life expectancy less than 12 months because of noncardiac comorbidities.
Patients having severe vein occlusion at femoral vein, ceiling vein, or inferior vena cava.
A patent foramen ovale with atrial septal aneurysm and right-to-left shunt
Symptomatic carotid artery disease
Patients with severe valvular heart disease
Patients who are currently participating in other clinical trials for any drug or medical device.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Division of Cardiology, Severance Cardiovascular Hospital
Seoul, 120-752

Other trials in South Korea

About this study

Total of 670 patients [left atrial appendage occlusion registry with 100 ACP/ 570 anti-coagulation registry: (285 Dabigatran plus aspirin) and (285 Dabigatran plus clopidogrel) therapy)] will be comparatively analyzed the safety and efficacy. Primary endpoints were a composite of death, non-fatal myocardial infarction, stroke, systemic embolism, and GUSTO bleeding (moderate to severe).

Conditions: Atrial Fibrillation, Coronary Artery Disease
Being tested: Dabigatrain plus aspirin, Dabigatrain plus clopidogrel, Amplazter Cardiac Plug (ACP)
Keywords: drug eluting stent, atrial appendage closure
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.

Dabigatrain plus aspirinDrug
Dabigatran (Pradaxa®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with atrial fibrillation. Aspirin is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop clopidogrel (maintain dabigatran + aspirin) at 3 months after PCI.
Dabigatrain plus clopidogrelDrug
Clopidogrel is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop aspirin (maintain dabigatran + clopidogrel) at 3 months after PCI.
Amplazter Cardiac Plug (ACP)Device
Patients allocated to the intervention group should be received percutaneous closure of the LAA by use of the ACP device (St. Jude Medical, St Paul, MN, USA).

Study groups in NCT02606552
Study group	Role	What they receive
Dabigatran plus aspirin	Active comparator	Medical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy)) Receives: Drug: Dabigatrain plus aspirin
Dabigatran plus clopidogrel	Experimental	medical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT) Receives: Drug: Dabigatrain plus clopidogrel
Amplazter Cardiac Plug (ACP)	Other	Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure Receives: Device: Amplazter Cardiac Plug (ACP)

What is being measured

The primary outcome is the main question the study is designed to answer.

MACCE (Major adverse cardiac and cerebrovascular events)
Measured: 5 years
GUSTO bleeding
Measured: 5 years

Secondary outcomes (1)

Occurence of procedural related complications
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 201623 Jun 2017

First posted17 Nov 2015 (estimated)
Study start20 Jul 2016
Primary completion23 Jun 2017
Study completion23 Jun 2017

Why it stopped: The number of patients registered for the study was low and it was expected to be difficult to derive the study results.

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.
More trials run by Yonsei 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02606552
Sponsor's protocol ID: 1-2014-0074
Status last verified: Jan 2019
First submitted: 12 Nov 2015
Last updated: 28 Jan 2019
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Left Atrial Appendage Closure Versus Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-Eluting Stent Implantation Due to Complex Coronary Artery Disease
ClinicalTrials.gov ID: NCT02606552
Acronym / sponsor ID: 1-2014-0074
Conditions: Atrial Fibrillation, Coronary Artery Disease
Keywords: drug eluting stent, atrial appendage closure
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The number of patients registered for the study was low and it was expected to be difficult to derive the study results.
Enrolment: 9 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: 20 Jul 2016
Primary completion: 23 Jun 2017 (actual)
Study completion: 23 Jun 2017 (actual)
First posted: 17 Nov 2015 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dabigatran plus aspirin	Active comparator	Drug: Dabigatrain plus aspirinMedical treatment with dabigatran plus aspirin after 3months triple therapy (Dabigatran plus DAPT (dual-antiplatelet therapy))
Dabigatran plus clopidogrel	Experimental	Drug: Dabigatrain plus clopidogrelmedical treatment with dabigatran plus clopidogrel after 3months triple therapy (Dabigatran plus DAPT)
Amplazter Cardiac Plug (ACP)	Other	Device: Amplazter Cardiac Plug (ACP)Amplazter Cardiac Plug (ACP) device-using percutaneous left atrial appendage closure

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients older than 20 years accompanying chronic atrial fibrillation with CHADS2 score ≥2
Patients with coronary artery disease (which requires DES) should receive the 2nd generation drug-eluting stent insertion treatment
Subjects and their legal representatives must understand the main purpose of this study, agree with relevant provisions, and sign to consent forms approved by IRBs of each institution.
Subjects should agree with the follow-up studies as (coronary angiography) and transesophageal echocardiography, etc.
Subjects should agree to follow our requests for post-operative follow-up visits.

Key exclusion criteria (15 listed)

Patients showing any hypersensitive reaction or reason for restriction to aspirin, heparin, clopidogrel, or warfarin, or otherwise, susceptible to contrast media, and therefore, who could not use those drugs and who were pregnant or breast feeding.
Comorbidities other than atrial fibrillation that required chronic warfarin use.
Patients diagnosed with progressive infection condition or endocarditis.
Patients who have been diagnosed with progressive gastric ulcer or upper gastrointestinal bleeding for last 3 months.
Hemodynamically unstable patients who needs inotropic supports.

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
Dabigatrain plus aspirinDabigatran (Pradaxa®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with atrial fibrillation. Aspirin is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop clopidogrel (maintain dabigatran + aspirin) at 3 months after PCI.	Drug	Dabigatran plus aspirin
Dabigatrain plus clopidogrelClopidogrel is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop aspirin (maintain dabigatran + clopidogrel) at 3 months after PCI.	Drug	Dabigatran plus clopidogrel
Amplazter Cardiac Plug (ACP)Patients allocated to the intervention group should be received percutaneous closure of the LAA by use of the ACP device (St. Jude Medical, St Paul, MN, USA).	Device	Amplazter Cardiac Plug (ACP)

Primary outcome

MACCE (Major adverse cardiac and cerebrovascular events)
Time frame: 5 years
GUSTO bleeding
Time frame: 5 years

1 secondary outcome

Occurence of procedural related complications
Time frame: 5 years

Results and safety

The study was stopped early (reason given: The number of patients registered for the study was low and it was expected to be difficult to derive the study results.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.

Related trials for Atrial Fibrillation

Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.

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?

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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 28 Jan 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 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

MACCE (Major adverse cardiac and cerebrovascular events) (time frame: 5 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 NCT02606552.

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 28 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.