Coronary Artery DiseasePhase 4SMART-CHOICE3NCT04418479
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3
A Phase 4 study testing Aspirin and Clopidogrel in people with Coronary Artery Disease, run by Joo-Yong Hahn at 1 site in South Korea.
Trial summary
This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more than 12 months for myocardial infarction [MI] and more than 6 months for non-MI) after… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Aspirin and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,506 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2020to 12 Nov 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 19 years of age
- Patients at high risk of recurrence of ischemic events who have undergone PCI using a DES and are receiving standard DAPT (12 months* or more for myocardial infarction and 6 months* or more for non-myocardial infarction)
- Patients at high risk for recurrent ischemic events, which were defined as one or more of the following clinical or lesion characteristics.
- Clinical characteristics
- Patients with prior myocardial infarction.
- Patients with diabetes mellitus who receive oral hypoglycemic agent or insulin.
Show all 16Show fewer
- Complex lesion characteristics Complex lesion was defined as one or more of the following.
- True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) and is able to assess the side branch ostium
- Chronic total occlusion (≥3 months) as target lesion
- PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)
- Long coronary lesions (implanted stent length ≥38 mm)
- Multi-vessel PCI (≥ 2 vessels treated at one PCI session)
- Multiple stent needed (≥ 3 stents per patient)
- In-stent restenosis lesion as target lesion
- Severely calcified lesion (encircling calcium in angiography) i . Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
Who cannot join
- Known hypersensitivity or contraindications to study medications (aspirin or clopidogrel)
- Patients who need continuous anticoagulant therapy.
- Patients who require DAPT due to atherosclerotic disease other than coronary artery disease
- Patients who are scheduled for revascularization treatment of coronary artery
- A patient who are taking single antiplatelet therapy at screening
- Pregnant or lactating women
- Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clopidogrel Versus Aspirin Monotherapy After Percutaneous Coronary Intervention and Standard Dual Antiplatelet Therapy in Patients At High Risk for Recurrent Ischemic Events
This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more than 12 months for myocardial infarction [MI] and more than 6 months for non-MI) after percutaneous coronary intervention (PCI) in patients at high risk of recurrent ischemic events.
Read the detailed description
After the introduction of the second-generation drug-eluting stents (DES), the rates of device-related failure or target lesion failure such as restenosis and stent thrombosis has been markedly decreased, compared with the era of bare-metal stents or first-generation DES. Nevertheless, the risk of ischemic events including very late stent thrombosis after percutaneous coronary intervention (PCI) has still remained even though the use of second-generation DES. In this regard, the ACC (American College of Cardiology)/AHA (American Heart Association) and ESC (European Society of Cardiology) guidelines recommended that dual antiplatelet therapy (DAPT) should be considered for 12 months or longer in patients presented with acute coronary syndrome (ACS) and for 6 months or longer in patients presented with stable ischemic heart disease (SIHD) after PCI with DES. In particular, patients presented with a high risk of ischemic events such as diabetes mellitus, myocardial infarction, or complex coronary lesions were associated with significantly increased future recurrent ischemic events after PCI with DES. In addition, maintenance of DAPT for 12 months or longer has been shown to reduce the recurrence of ischemic events up to 44% in patients treated with PCI for complex coronary artery lesion; therefore the current guideline recommended that prolonged DAPT might be considered when performing complex PCI. However, prolonged DAPT increases bleeding risk and cost. Endoscopic, dental, and surgical procedures are often delayed due to prolonged DAPT, which may affect the patient's quality of life. Therefore, to determine the optimal or minimal necessary duration of DAPT is very important.
The other important issue is that which antiplatelet agent is more appropriate after DAPT. Aspirin monotherapy has been recommended traditionally. However, there is no randomized comparison study between aspirin monotherapy versus clopidogrel monotherapy after DAPT in patients undergoing PCI with DES. Furthermore, clopidogrel is also actively used as a monotherapy after DAPT in real-world practice. In CAPRIE (clopidogrel versus aspirin in patients at risk of ischemic events) trial, clopidogrel showed a superior efficacy in preventing ischemic events compared with aspirin. Moreover, the incidence of gastrointestinal bleeding was significantly lower with clopidogrel than with aspirin. Clopidogrel monotherapy can reduce ischemic events and bleeding risk compared with aspirin monotherapy.
Therefore, the purpose of the SMART-CHOICE 3 (SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3) trial is to determine the efficacy and safety of clopidogrel monotherapy compared with aspirin monotherapy beyond the standard duration of DAPT after PCI with current-generation DES in patients at high risk for recurrent ischemic events.
- Conditions
- Coronary Artery Disease
- Being tested
- Aspirin, Clopidogrel
- Keywords
- Percutaneous Coronary Intervention, Antiplatelet Therapy, Complex Coronary Lesion, Aspirin, Clopidogrel
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Aspirin monotherapy
Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients who completed standard duration of dual antiplatelet therapy (DAPT) and who were at high risk for recurrent ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).
This group will be taken aspirin 100 mg once daily during the study period.
ClopidogrelDrug
Also called Clopidogrel monotherapy
Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients who completed standard duration of dual antiplatelet therapy (DAPT) and who were at high risk for recurrent ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).
This group will be taken clopidogrel 75 mg once daily during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin monotherapy arm | Active comparator | Patients will receive 100 mg of aspirin once daily. Receives: Drug: Aspirin |
| Clopidogrel monotherapy arm | Experimental | Patients will receive 75 mg of clopidogrel once daily. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of major adverse cardiac and cerebrovascular event (MACCE)
a composite of all-cause death, myocardial infarction, or stroke
Measured: 1-year after last patient enrollment
Secondary outcomes (19)
Rates of all-cause death
Death by any cause
Measured: 1-year after last patient enrollment
Rates of cardiovascular death
Death by cardiovascular cause
Measured: 1-year after last patient enrollment
Rates of myocardial infarction
Myocardial infarction
Measured: 1-year after last patient enrollment
Rates of stroke
Stroke
Measured: 1-year after last patient enrollment
Rates of stent thrombosis
definite or probable by Academic Research Consortium [ARC] definition
Measured: 1-year after last patient enrollment
Rates of all-cause death or MI
A composite of all-cause death or MI
Measured: 1-year after last patient enrollment
Rates of cardiovascular death or MI
A composite of cardiovascular death or MI
Measured: 1-year after last patient enrollment
Rates of cardiovascular death, MI, or stroke
A composite of cardiovascular death, MI, or stroke
Measured: 1-year after last patient enrollment
Rates of cardiovascular death, MI, or stent thrombosis
A composite of cardiovascular death, MI, or stent thrombosis
Measured: 1-year after last patient enrollment
Rates of major Bleeding
BARC [Bleeding Academic Research Consortium] types 3 or 5
Measured: 1-year after last patient enrollment
Rates of bleeding
BARC [Bleeding Academic Research Consortium] types 2, 3, or 5
Measured: 1-year after last patient enrollment
Rates of upper gastrointestinal clinical event
A composite of upper gastrointestinal clinical event
Measured: 1-year after last patient enrollment
Rates of gastrointestinal ulcer or bleeding
A composite of gastrointestinal ulcer or bleeding
Measured: 1-year after last patient enrollment
New diagnosed rates of gastroesophageal reflux disease (GERD)
Gastroesophageal reflux disease (GERD)
Measured: 1-year after last patient enrollment
Rates of NACE (Net adverse clinical events)
MACCE + BARC type 3 or 5 bleeding
Measured: 1-year after last patient enrollment
Rates of Target-lesion revascularization (TLR)
Target-lesion revascularization (TLR)
Measured: 1-year after last patient enrollment
Rates of Target-vessel revascularization (TVR)
Target-vessel revascularization (TVR)
Measured: 1-year after last patient enrollment
Rates of any revascularization
any revascularization including TLR, TVR, and non-TVR re-percutaneous coronary intervention
Measured: 1-year after last patient enrollment
Medical cost
Medical cost
Measured: 1-year after last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start10 Aug 2020
- Primary completion31 Oct 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open-label, two-arm, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 5,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joo-Yong Hahn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joo-Yong Hahn, Samsung Medical Center
- Investigators
- Joo-Yong Hahn, MD, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418479
- Sponsor's protocol ID
- CHOICE-3
- Acronym
- SMART-CHOICE3
- Status last verified
- Jan 2025
- First submitted
- 1 Jun 2020
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JM, Gim DH, Park YH, Lee JY, Jeong JO, Kim CJ, Yun KH, Lee HC, Chang K, Park MW, Bae JW, Doh JH, Cho BR, Kim HY, Kim W, Kim U, Rha SW, Hong YJ, Lee HJ, Ahn SG, Kim DI, Cho JH, Her SH, Jeon DS, Han SH, Lee JB, Lee CW, Kang D, Choi KH, Park TK, Yang JH, Lee SY, Choi SH, Gwon HC, Song YB, Hahn JY; SMART-CHOICE 3 Investigators. Clopidogrel Versus Aspirin Monotherapy According to Atherothrombotic Risk Profile. Circ Cardiovasc Interv. 2026 Oct 29:e017277. doi: 10.1161/CIRCINTERVENTIONS.126.017277. Online ahead of print.
PubMed 42953942Lee SY, Joo D, Lee JM, Park YH, Lee JY, Jeong JO, Kim CJ, Lee HC, Chang K, Park MW, Bae JW, Doh JH, Cho BR, Kim HY, Kim W, Kim U, Rha SW, Hong YJ, Lee HJ, Ahn SG, Kim DI, Cho JH, Her SH, Jeon DS, Han SH, Lee JB, Lee CW, Kang D, Choi KH, Park TK, Yang JH, Lee SY, Choi SH, Gwon HC, Song YB, Hahn JY, Yun KH; SMART-CHOICE 3 Investigators. Clopidogrel vs Aspirin According to Diabetes Mellitus: A Prespecified Analysis of the SMART-CHOICE 3 Trial. JACC Cardiovasc Interv. 2026 Jun 22:S1936-8798(26)01539-6. doi: 10.1016/j.jcin.2026.05.013. Online ahead of print.
PubMed 42461194Choi KH, Park YH, Lee JY, Jeong JO, Kim CJ, Yun KH, Lee HC, Chang K, Park MW, Bae JW, Doh JH, Cho BR, Kim HY, Kim W, Kim U, Rha SW, Hong YJ, Lee HJ, Ahn SG, Kim DI, Cho JH, Her SH, Jeon DS, Han SH, Lee JB, Lee CW, Kang D, Lee JM, Park TK, Yang JH, Lee SY, Choi SH, Gwon HC, Song YB, Hahn JY; SMART-CHOICE 3 investigators. Efficacy and safety of clopidogrel versus aspirin monotherapy in patients at high risk of subsequent cardiovascular event after percutaneous coronary intervention (SMART-CHOICE 3): a randomised, open-label, multicentre trial. Lancet. 2025 Apr 12;405(10486):1252-1263. doi: 10.1016/S0140-6736(25)00449-0. Epub 2025 Mar 30.
PubMed 40174599
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel Versus Aspirin Monotherapy After Percutaneous Coronary Intervention and Standard Dual Antiplatelet Therapy in Patients At High Risk for Recurrent Ischemic Events
- ClinicalTrials.gov ID
- NCT04418479
- Acronym / sponsor ID
- SMART-CHOICE3 / CHOICE-3
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Antiplatelet Therapy, Complex Coronary Lesion, Aspirin, Clopidogrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,506 participants (actual)
- Lead sponsor
- Joo-Yong HahnUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 5 Jun 2020 (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 is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more than 12 months for myocardial infarction [MI] and more than 6 months for non-MI) after percutaneous coronary intervention (PCI) in patients at high risk of recurrent ischemic events.
Detailed description
After the introduction of the second-generation drug-eluting stents (DES), the rates of device-related failure or target lesion failure such as restenosis and stent thrombosis has been markedly decreased, compared with the era of bare-metal stents or first-generation DES. Nevertheless, the risk of ischemic events including very late stent thrombosis after percutaneous coronary intervention (PCI) has still remained even though the use of second-generation DES. In this regard, the ACC (American College of Cardiology)/AHA (American Heart Association) and ESC (European Society of Cardiology) guidelines recommended that dual antiplatelet therapy (DAPT) should be considered for 12 months or longer in patients presented with acute coronary syndrome (ACS) and for 6 months or longer in patients presented with stable ischemic heart disease (SIHD) after PCI with DES. In particular, patients presented with a high risk of ischemic events such as diabetes mellitus, myocardial infarction, or complex coronary lesions were associated with significantly increased future recurrent ischemic events after PCI with DES. In addition, maintenance of DAPT for 12 months or longer has been shown to reduce the recurrence of ischemic events up to 44% in patients treated with PCI for complex coronary artery lesion; therefore the current guideline recommended that prolonged DAPT might be considered when performing complex PCI. However, prolonged DAPT increases bleeding risk and cost. Endoscopic, dental, and surgical procedures are often delayed due to prolonged DAPT, which may affect the patient's quality of life. Therefore, to determine the optimal or minimal necessary duration of DAPT is very important.
The other important issue is that which antiplatelet agent is more appropriate after DAPT. Aspirin monotherapy has been recommended traditionally. However, there is no randomized comparison study between aspirin monotherapy versus clopidogrel monotherapy after DAPT in patients undergoing PCI with DES. Furthermore, clopidogrel is also actively used as a monotherapy after DAPT in real-world practice. In CAPRIE (clopidogrel versus aspirin in patients at risk of ischemic events) trial, clopidogrel showed a superior efficacy in preventing ischemic events compared with aspirin. Moreover, the incidence of gastrointestinal bleeding was significantly lower with clopidogrel than with aspirin. Clopidogrel monotherapy can reduce ischemic events and bleeding risk compared with aspirin monotherapy.
Therefore, the purpose of the SMART-CHOICE 3 (SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3) trial is to determine the efficacy and safety of clopidogrel monotherapy compared with aspirin monotherapy beyond the standard duration of DAPT after PCI with current-generation DES in patients at high risk for recurrent ischemic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-label, two-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aspirin monotherapy arm | Active comparator | Drug: AspirinPatients will receive 100 mg of aspirin once daily. |
| Clopidogrel monotherapy arm | Experimental | Drug: ClopidogrelPatients will receive 75 mg of clopidogrel once daily. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject must be at least 19 years of age
- Patients at high risk of recurrence of ischemic events who have undergone PCI using a DES and are receiving standard DAPT (12 months* or more for myocardial infarction and 6 months* or more for non-myocardial infarction)
- Patients at high risk for recurrent ischemic events, which were defined as one or more of the following clinical or lesion characteristics.
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
Key exclusion criteria (7 listed)
- Known hypersensitivity or contraindications to study medications (aspirin or clopidogrel)
- Patients who need continuous anticoagulant therapy.
- Patients who require DAPT due to atherosclerotic disease other than coronary artery disease
- Patients who are scheduled for revascularization treatment of coronary artery
- A patient who are taking single antiplatelet therapy at screening
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 |
|---|---|---|
| AspirinAlso: Aspirin monotherapyRandomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients who completed standard duration of dual antiplatelet therapy (DAPT) and who were at high risk for recurrent ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). This group will be taken aspirin 100 mg once daily during the study period. | Drug | Aspirin monotherapy arm |
| ClopidogrelAlso: Clopidogrel monotherapyRandomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients who completed standard duration of dual antiplatelet therapy (DAPT) and who were at high risk for recurrent ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). This group will be taken clopidogrel 75 mg once daily during the study period. | Drug | Clopidogrel monotherapy arm |
Primary outcome
Rates of major adverse cardiac and cerebrovascular event (MACCE)
Time frame: 1-year after last patient enrollment
a composite of all-cause death, myocardial infarction, or stroke
19 secondary outcomes
Rates of all-cause death
Time frame: 1-year after last patient enrollment
Rates of cardiovascular death
Time frame: 1-year after last patient enrollment
Rates of myocardial infarction
Time frame: 1-year after last patient enrollment
Rates of stroke
Time frame: 1-year after last patient enrollment
Rates of stent thrombosis
Time frame: 1-year after last patient enrollment
Rates of all-cause death or MI
Time frame: 1-year after last patient enrollment
Rates of cardiovascular death or MI
Time frame: 1-year after last patient enrollment
Rates of cardiovascular death, MI, or stroke
Time frame: 1-year after last patient enrollment
Rates of cardiovascular death, MI, or stent thrombosis
Time frame: 1-year after last patient enrollment
Rates of major Bleeding
Time frame: 1-year after last patient enrollment
Rates of bleeding
Time frame: 1-year after last patient enrollment
Rates of upper gastrointestinal clinical event
Time frame: 1-year after last patient enrollment
Rates of gastrointestinal ulcer or bleeding
Time frame: 1-year after last patient enrollment
New diagnosed rates of gastroesophageal reflux disease (GERD)
Time frame: 1-year after last patient enrollment
Rates of NACE (Net adverse clinical events)
Time frame: 1-year after last patient enrollment
Rates of Target-lesion revascularization (TLR)
Time frame: 1-year after last patient enrollment
Rates of Target-vessel revascularization (TVR)
Time frame: 1-year after last patient enrollment
Rates of any revascularization
Time frame: 1-year after last patient enrollment
Medical cost
Time frame: 1-year after last patient enrollment
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 30 Jan 2025.
- Derived from this study: PubMed 42953942Lee JM, Gim DH, Park YH, Lee JY, Jeong JO, Kim CJ, Yun KH, Lee HC, Chang K, Park MW, Bae JW, Doh JH, Cho BR, Kim HY, Kim W, Kim U, Rha SW, Hong YJ, Lee HJ, Ahn SG, Kim DI, Cho JH, Her SH, Jeon DS, Han SH, Lee JB, Lee CW, Kang D, Choi KH, Park TK, Yang JH, Lee SY, Choi SH, Gwon HC, Song YB, Hahn JY; SMART-CHOICE 3 Investigators. Clopidogrel Versus Aspirin Monotherapy According to Atherothrombotic Risk Profile. Circ Cardiovasc Interv. 2026 Oct 29:e017277. doi: 10.1161/CIRCINTERVENTIONS.126.017277. Online ahead of print.
- Derived from this study: PubMed 42461194Lee SY, Joo D, Lee JM, Park YH, Lee JY, Jeong JO, Kim CJ, Lee HC, Chang K, Park MW, Bae JW, Doh JH, Cho BR, Kim HY, Kim W, Kim U, Rha SW, Hong YJ, Lee HJ, Ahn SG, Kim DI, Cho JH, Her SH, Jeon DS, Han SH, Lee JB, Lee CW, Kang D, Choi KH, Park TK, Yang JH, Lee SY, Choi SH, Gwon HC, Song YB, Hahn JY, Yun KH; SMART-CHOICE 3 Investigators. Clopidogrel vs Aspirin According to Diabetes Mellitus: A Prespecified Analysis of the SMART-CHOICE 3 Trial. JACC Cardiovasc Interv. 2026 Jun 22:S1936-8798(26)01539-6. doi: 10.1016/j.jcin.2026.05.013. Online ahead of print.
- Derived from this study: PubMed 40174599Choi KH, Park YH, Lee JY, Jeong JO, Kim CJ, Yun KH, Lee HC, Chang K, Park MW, Bae JW, Doh JH, Cho BR, Kim HY, Kim W, Kim U, Rha SW, Hong YJ, Lee HJ, Ahn SG, Kim DI, Cho JH, Her SH, Jeon DS, Han SH, Lee JB, Lee CW, Kang D, Lee JM, Park TK, Yang JH, Lee SY, Choi SH, Gwon HC, Song YB, Hahn JY; SMART-CHOICE 3 investigators. Efficacy and safety of clopidogrel versus aspirin monotherapy in patients at high risk of subsequent cardiovascular event after percutaneous coronary intervention (SMART-CHOICE 3): a randomised, open-label, multicentre trial. Lancet. 2025 Apr 12;405(10486):1252-1263. doi: 10.1016/S0140-6736(25)00449-0. Epub 2025 Mar 30.
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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.
Joo-Yong Hahn, MD, PhD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and Clopidogrel in people with Coronary Artery Disease, run by Joo-Yong Hahn 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 16 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 30 Jan 2025. 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?
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?
Rates of major adverse cardiac and cerebrovascular event (MACCE) (time frame: 1-year after last patient enrollment). 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 NCT04418479, which also lists 3 linked publications.
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 30 Jan 2025.