Chronic Coronary SyndromeCABG_DAPT_SAPTNCT06881901
Antiplatelet Strategy for CCS Patients Undergoing CABG
An observational study of Chronic Coronary Syndrome and Coronary Artery Bypass Graft CABG, run by Samsung Medical Center.
Trial summary
To evaluate the long-term outcomes of different antiplatelet strategies, including DAPT, aspirin monotherapy, and clopidogrel monotherapy, in CCS patients undergoing CABG. A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome, Coronary Artery Bypass Graft CABG
- How many people
- 29,898 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2022
- 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: Patients who were prescribed antiplatete therapy after undergoing CABG
Who may be able to join
- Patients with underwent Coronary artery bypass surgery (CABG) between January 2010 and December 2020
Who cannot join
- In-hospital death
- Not prescribed SAPT or DAPT
- Received CABG due to myocardial infarction or had myocardial infarction
- Received CABG due to unstable angina or had unstable angina
- History of PCI
- Pre-existing Intracranial hemorrhage or gastrointestinal bleeding
- Oral anticoagulant prescription at discharge
About this study
Official title: Clopidogrel Monotherapy in Patients with Chronic Coronary Syndrome Following Coronary Artery Bypass Grafting : a Target Trial Emulation
To evaluate the long-term outcomes of different antiplatelet strategies, including DAPT, aspirin monotherapy, and clopidogrel monotherapy, in CCS patients undergoing CABG. A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.
Read the detailed description
The use of antiplatelet agents is crucial in preventing atherothrombotic complications and maintaining graft patency after coronary artery bypass grafting (CABG). While dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended for one year in patients undergoing CABG for acute coronary syndrome (ACS), the optimal antiplatelet strategy for chronic coronary syndrome (CCS) remains unclear. In fact, current guidelines show discrepancies, with the American Heart Association/American College of Cardiology (AHA/ACC) recommending DAPT for one year to reduce the risk of saphenous vein graft (SVG) occlusion (Class IIb), while the European Society of Cardiology (ESC) recommends switching to aspirin monotherapy to reduce bleeding risk and considers DAPT only for high-risk patients (Class IIb). However, aspirin monotherapy may also not be the optimal alternative due to its limited efficacy in preventing thrombotic events and its inability to significantly reduce major bleeding compared to DAPT. Recently, clopidogrel monotherapy has emerged as a promising alternative, potentially offering both ischemic protection and a lower bleeding risk compared to DAPT even compared to aspirin monotherapy. An observational study comparing clopidogrel monotherapy with clopidogrel plus aspirin after CABG found that clopidogrel monotherapy demonstrated comparable to the combination therapy group. While this suggests that clopidogrel monotherapy could be a viable alternative, previous study was limited by its short follow-up duration and lack of bleeding outcome assessment. Thus, the investigators performed target trial emulation to evaluate long-term ischemic and bleeding outcomes associated with DAPT, aspirin monotherapy, and clopidogrel monotherapy in CCS patients following CABG.
- Keywords
- antiplatelet drug, Dual antiplatelet therapy, Single antiplatelet therapy
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 (aspirin + clopidogrel) at the date of discharge from te index hospitalization for CABG | |
| Aspirin monotherapy | Patients who were prescribed single antiplatelet therapy (aspirin) at the date of discharge from te index hospitalization for CABG | |
| Clopidogrel monotherapy | Patients who were prescribed single antiplatelet therapy (clopidogrel) at the date of discharge from te index hospitalization for CABG |
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, spontaneous MI, and stroke
Measured: 10 year after CABG
Major GI bleeding
Major GI bleeding requiring transfusion
Measured: 10 year after CABG
Secondary outcomes (5)
All cause death
death from any cause
Measured: 10 year after CABG
Spontaneous myocardial infarction
Myocardial infarction with hospitalozation
Measured: 10 year after CABG
Stroke
Stroke after CABG
Measured: 10 year after CABG
Repeat revascularization
Additional PCI or CABG after discharge
Measured: 10 year after CABG
Bleeding evet
Any bleeding requiring transfusion
Measured: 10 year after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 Chronic Coronary SyndromeStudies 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
- 29,898 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
- NCT06881901
- Sponsor's protocol ID
- Antiplatelet After CABG
- Acronym
- CABG_DAPT_SAPT
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim O, Seo J, Min SS, Park TK, Lee JM, Cho J, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Chung SR, Cho YH, Jeong DS, Sung K, Kim WS, Kang D, Choi KH. Clopidogrel Monotherapy in Patients With Chronic Coronary Syndrome Following Coronary Artery Bypass Grafting: A Nationwide Cohort Study. Korean Circ J. 2026 Apr 28. doi: 10.4070/kcj.2025.0430. Online ahead of print.
PubMed 42204739
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel Monotherapy in Patients with Chronic Coronary Syndrome Following Coronary Artery Bypass Grafting : a Target Trial Emulation
- ClinicalTrials.gov ID
- NCT06881901
- Acronym / sponsor ID
- CABG_DAPT_SAPT / Antiplatelet After CABG
- Keywords
- antiplatelet drug, Dual antiplatelet therapy, Single antiplatelet therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29,898 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 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.
To evaluate the long-term outcomes of different antiplatelet strategies, including DAPT, aspirin monotherapy, and clopidogrel monotherapy, in CCS patients undergoing CABG. A retrospective, population-based cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.
Detailed description
The use of antiplatelet agents is crucial in preventing atherothrombotic complications and maintaining graft patency after coronary artery bypass grafting (CABG). While dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended for one year in patients undergoing CABG for acute coronary syndrome (ACS), the optimal antiplatelet strategy for chronic coronary syndrome (CCS) remains unclear. In fact, current guidelines show discrepancies, with the American Heart Association/American College of Cardiology (AHA/ACC) recommending DAPT for one year to reduce the risk of saphenous vein graft (SVG) occlusion (Class IIb), while the European Society of Cardiology (ESC) recommends switching to aspirin monotherapy to reduce bleeding risk and considers DAPT only for high-risk patients (Class IIb). However, aspirin monotherapy may also not be the optimal alternative due to its limited efficacy in preventing thrombotic events and its inability to significantly reduce major bleeding compared to DAPT. Recently, clopidogrel monotherapy has emerged as a promising alternative, potentially offering both ischemic protection and a lower bleeding risk compared to DAPT even compared to aspirin monotherapy. An observational study comparing clopidogrel monotherapy with clopidogrel plus aspirin after CABG found that clopidogrel monotherapy demonstrated comparable to the combination therapy group. While this suggests that clopidogrel monotherapy could be a viable alternative, previous study was limited by its short follow-up duration and lack of bleeding outcome assessment. Thus, the investigators performed target trial emulation to evaluate long-term ischemic and bleeding outcomes associated with DAPT, aspirin monotherapy, and clopidogrel monotherapy in CCS patients following CABG.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual antiplatelet therapy | – | –Patients who were prescribed dual antiplatelet therapy (aspirin + clopidogrel) at the date of discharge from te index hospitalization for CABG |
| Aspirin monotherapy | – | –Patients who were prescribed single antiplatelet therapy (aspirin) at the date of discharge from te index hospitalization for CABG |
| Clopidogrel monotherapy | – | –Patients who were prescribed single antiplatelet therapy (clopidogrel) at the date of discharge from te index hospitalization for CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were prescribed antiplatete therapy after undergoing CABG
Key inclusion criteria (1 listed)
- Patients with underwent Coronary artery bypass surgery (CABG) between January 2010 and December 2020
Key exclusion criteria (7 listed)
- In-hospital death
- Not prescribed SAPT or DAPT
- Received CABG due to myocardial infarction or had myocardial infarction
- Received CABG due to unstable angina or had unstable angina
- History of PCI
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: 10 year after CABG
Composite of all cause death, spontaneous MI, and stroke
Major GI bleeding
Time frame: 10 year after CABG
Major GI bleeding requiring transfusion
5 secondary outcomes
All cause death
Time frame: 10 year after CABG
Spontaneous myocardial infarction
Time frame: 10 year after CABG
Stroke
Time frame: 10 year after CABG
Repeat revascularization
Time frame: 10 year after CABG
Bleeding evet
Time frame: 10 year after CABG
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 18 Mar 2025.
- Derived from this study: PubMed 42204739Kim O, Seo J, Min SS, Park TK, Lee JM, Cho J, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Chung SR, Cho YH, Jeong DS, Sung K, Kim WS, Kang D, Choi KH. Clopidogrel Monotherapy in Patients With Chronic Coronary Syndrome Following Coronary Artery Bypass Grafting: A Nationwide Cohort Study. Korean Circ J. 2026 Apr 28. doi: 10.4070/kcj.2025.0430. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
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 Chronic Coronary Syndrome and Coronary Artery Bypass Graft CABG, 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 18 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: 10 year after CABG). 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 NCT06881901, 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 18 Mar 2025.