Abdominal Aortic Aneurysms (AAA)EVAR_DAPT_SAPTNCT06876727
Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair
An observational study of Abdominal Aortic Aneurysms (AAA) and Endovascular Aneurysm Repair (EVAR), run by Samsung Medical Center.
Trial summary
This study was a target trial emulation using the National Health Claims database established by the Korean National Health Insurance Service (K-NHIS). 8,325 patients were included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms (AAA), Endovascular Aneurysm Repair (EVAR)
- How many people
- 8,325 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 30 Sep 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent EVAR for AAA and were successfully discharged and prescribe any antiplatelet therapy.
Who may be able to join
- All patients who underwent EVAR for AAA and were successfully discharged
Who cannot join
- Patients who had experienced a myocardial infarction
- Patients who had experienced a stroke
- Patients who had experienced percutaneous coronary intervention
- Patients who had history of peripheral disease
- Patients who had major bleeding event within 1 year of admission
- Those prescribed non-vitamin K antagonist oral anticoagulant or warfarin
- Patients who did not prescribe any antiplatelet therapy
About this study
Official title: A Target Trial Emulation for Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair
This study was a target trial emulation using the National Health Claims database established by the Korean National Health Insurance Service (K-NHIS). 8,325 patients were included.
Read the detailed description
Among these patients, any patients who were prescribed SAPT or DAPT at the date of discharge from the index hospitalization for standard EVAR were defined as being in the SAPT group (N=4,162) and the DAPT group (N=4,163), respectively.
- Keywords
- Abdominal Aortic Aneurysms (AAA), Endovascular Aneurysm Repair (EVAR), Single antiplatelet therapy, Dual antiplatelet therapy
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dual antiplatelet therapy | Patients who were prescribed dual antiplatelet therapy at the date of discharge from the index hospitalization for standard EVAR | |
| Single antiplatelet therapy | Patients who were prescribed single antiplatelet therapy at the date of discharge from the index hospitalization for standard EVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events (MACCE)
composite of all-cause death, myocardial infarction (MI), or ischemic stroke
Measured: 1 year after EVAR
Major or clinically relevant non-major bleeding
Diagnostic codes in the primary or secondary position and transfusion receipt
Measured: 1 year after EVAR
Re-intervention or surgery for AAAs
Re-intervention or surgery for AAAs
Measured: 1 year after EVAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Jan 2003
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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 Abdominal Aortic Aneurysms (AAA)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 8,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876727
- Sponsor's protocol ID
- Antiplatelet After EVAR
- Acronym
- EVAR_DAPT_SAPT
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi KH, Kang D, Nam J, Park TK, Song MG, Seo TS, Yang WJ, Choi SH. Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair: A Target Trial Emulation. J Am Heart Assoc. 2025 Oct 21;14(20):e044102. doi: 10.1161/JAHA.125.044102. Epub 2025 Oct 9.
PubMed 41065286
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Target Trial Emulation for Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair
- ClinicalTrials.gov ID
- NCT06876727
- Acronym / sponsor ID
- EVAR_DAPT_SAPT / Antiplatelet After EVAR
- Keywords
- Abdominal Aortic Aneurysms (AAA), Endovascular Aneurysm Repair (EVAR), Single antiplatelet therapy, Dual antiplatelet therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,325 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Mar 2025 (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 was a target trial emulation using the National Health Claims database established by the Korean National Health Insurance Service (K-NHIS). 8,325 patients were included.
Detailed description
Among these patients, any patients who were prescribed SAPT or DAPT at the date of discharge from the index hospitalization for standard EVAR were defined as being in the SAPT group (N=4,162) and the DAPT group (N=4,163), respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual antiplatelet therapy | – | –Patients who were prescribed dual antiplatelet therapy at the date of discharge from the index hospitalization for standard EVAR |
| Single antiplatelet therapy | – | –Patients who were prescribed single antiplatelet therapy at the date of discharge from the index hospitalization for standard EVAR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent EVAR for AAA and were successfully discharged and prescribe any antiplatelet therapy.
Key inclusion criteria (1 listed)
- All patients who underwent EVAR for AAA and were successfully discharged
Key exclusion criteria (7 listed)
- Patients who had experienced a myocardial infarction
- Patients who had experienced a stroke
- Patients who had experienced percutaneous coronary intervention
- Patients who had history of peripheral disease
- Patients who had major bleeding event within 1 year of admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 1 year after EVAR
composite of all-cause death, myocardial infarction (MI), or ischemic stroke
Major or clinically relevant non-major bleeding
Time frame: 1 year after EVAR
Diagnostic codes in the primary or secondary position and transfusion receipt
Re-intervention or surgery for AAAs
Time frame: 1 year after EVAR
Re-intervention or surgery for AAAs
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 14 Mar 2025.
- Derived from this study: PubMed 41065286Choi KH, Kang D, Nam J, Park TK, Song MG, Seo TS, Yang WJ, Choi SH. Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair: A Target Trial Emulation. J Am Heart Assoc. 2025 Oct 21;14(20):e044102. doi: 10.1161/JAHA.125.044102. Epub 2025 Oct 9.
- Individual participant dataSharing planned: No
Related trials for Abdominal Aortic Aneurysms (AAA)
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysms (AAA) and Endovascular Aneurysm Repair (EVAR), run by Samsung Medical Center.
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 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 14 Mar 2025. 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?
Major adverse cardiac and cerebrovascular events (MACCE) (time frame: 1 year after EVAR). The study lists 3 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 NCT06876727, 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 14 Mar 2025.