Coronary Artery DiseasePhase 4ATTEMPTNCT04014803
Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion
A Phase 4 study testing Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin in people with Coronary Artery Disease, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
This study is a prospective, open label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous coronary intervention with drug eluting stents for complex coronary lesions. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 13 Jan 2020to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① Subject must be at least 19 years of age
- ② Subject who can verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
- ③ Patients undergoing elective PCI as follows:
- True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size
- 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)
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- Long coronary lesions (expected 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)
- Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery
Who cannot join
- ① Hemodynamic instability or cardiogenic shock
- ② Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.)
- ③ Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke
- ④ Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel)
- ⑤ Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- ⑥ Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
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- ⑦ Patients presenting with biomarker positive acute coronary syndrome
- ⑧ Patients chronically taking prasugrel or ticagrelor (≥1 week)
- ⑨ Subjects ≥75 years of age or <60 kg of body weight
- ⑩ Patients taking warfarin or novel oral anticoagulants (dabigatran, rivaroxaban, edoxaban, or apixaban)
- Eligible patients will be randomly assigned to treatment arms, stratified by participating centers, presence of diabetes mellitus, and stent types.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Joo-Yong Hahn, MD, PhD, 82-2-3410-6653, ichjy1@gmail.com
- Recruiting
Samsung Medical Center
Seoul
About this study
Official title: Aspirin and a Potent P2Y12 Inhibitor Versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment (SMART-ATTEMPT)
This study is a prospective, open label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous coronary intervention with drug eluting stents for complex coronary lesions.
Read the detailed description
Over the past several decades, dual antiplatelet therapy (DAPT) with the combination of aspirin and a P2Y12 inhibitor has become an essential treatment in patients undergoing percutaneous coronary intervention (PCI) to reduce ischemic events. Although the optimal duration of DAPT still remains controversial in patients with coronary artery disease, the recommended duration of maintenance of DAPT for patients undergoing PCI with drug-eluting stent is ≥12 months for those with acute coronary syndrome (ACS), and ≥6 months for those with stable coronary artery disease according to the current guidelines. However, individualized approach based on ischemic versus bleeding risks assessment is needed to determine the optimal duration of DAPT in various population.
Several studies reported that patients undergoing PCI for complex lesions had significantly higher rates of ischemic events than those with non-complex lesions. Moreover, prolonged DAPT of aspirin and clopidogrel more than 1 year significantly reduced the risk of cardiac ischemic events up to 44% in patients undergoing PCI for complex coronary lesions, and the current guideline recommends prolonged DAPT duration may be considered in patients undergoing complex PCI. Apart from prolonged use of DAPT, use of more potent P2Y12 inhibitor than clopidogrel may be another strategy to reduce ischemic events in patients undergoing PCI for complex coronary lesions. Prasugrel, a new thienopyridine, inhibits platelet aggregation more rapidly and potently than clopidogrel. In the TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel) study, prasugrel reduced ischemic events compared with clopidogrel in patients with acute coronary syndrome. Moreover, low dose prasugrel also reduced ischemic events without an excessive bleeding risk in Japanese population. Therefore, DAPT of aspirin and prasugrel would reduce recurrent ischemic events than DAPT of aspirin and clopidogrel in patients undergoing PCI for complex lesions, a high risk group of ischemic events, even when they do not present with myocardial infarction. So far, there have been no data on this issue.
The aim of the SMART-ATTEMPT (Aspirin and a PoTent P2Y12 inhibitor versus aspirin and clopidogrel Therapy in patients undergoing Elective percutaneous coronary intervention for coMPlex lesion Treatment) trial is to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective PCI for complex lesions.
- Conditions
- Coronary Artery Disease
- Being tested
- Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
- Keywords
- Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Complex Coronary Lesion
- 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.
Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirinDrug
Also called Prasugrel plus Aspirin or Clopidogrel plus Aspirin
Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin will be given according to the allocated arms in patients undergoing elective percutaneous coronary intervention for complex coronary lesion
- Prasugrel plus Aspirin arm
- Clopidogrel plus Aspirin arm
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel plus Aspirin arm | Active comparator | Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of prasugrel 60 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus prasugrel 10 mg once daily* will be given for one year.
* Based on previous studies including PRASFIT-ACS (PRASugrel compared with clopidogrel For Japanese patIenTs with ACS undergoing PCI) or TRILOGY ACS (The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes), maintenance dose can be reduced to 5 mg once daily in patients with high bleeding risk or by investigator's medical judgement. Receives: Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin |
| Clopidogrel plus Aspirin arm | Active comparator | Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of clopidogrel 600 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for one year. Receives: Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE)
A composite of death, myocardial infarction, or stent thrombosis
Measured: 1-year after randomization
Secondary outcomes (17)
All-cause death
Death by any cause
Measured: 1-year after randomization
Cardiac death
Death by cardiac cause
Measured: 1-year after randomization
Myocardial infarction
Myocardial infarction
Measured: 1-year after randomization
Stent thrombosis
Definite or probable stent thrombosis
Measured: 1-year after randomization
Target lesion revascularization
Repeat revascularization for target lesion of index PCI
Measured: 1-year after randomization
Target vessel revascularization
Repeat revascularization for target vessel of index PCI
Measured: 1-year after randomization
Any revascularization
Any repeat revascularization
Measured: 1-year after randomization
A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization
A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization
Measured: 1-year after randomization
A composite of all-cause death/myocardial infarction
A composite of all-cause death/myocardial infarction
Measured: 1-year after randomization
A composite of cardiac death/myocardial infarction
A composite of cardiac death/myocardial infarction
Measured: 1-year after randomization
Cerebrovascular accident
Cerebrovascular accident
Measured: 1-year after randomization
A composite of all-cause death/myocardial infarction/cerebrovascular accident
A composite of all-cause death/myocardial infarction/cerebrovascular accident
Measured: 1-year after randomization
A composite of cardiac death/myocardial infarction/cerebrovascular accident
A composite of cardiac death/myocardial infarction/cerebrovascular accident
Measured: 1-year after randomization
A composite of cardiac death/myocardial infarction/stent thrombosis
A composite of cardiac death/myocardial infarction/stent thrombosis
Measured: 1-year after randomization
Bleeding by BARC types 3 or 5
Bleeding defined by Bleeding Academic Research Consortium (BARC) types 3 or 5
Measured: 1-year after randomization
Bleeding by BARC types 2, 3, or 5
Bleeding defined by BARC types 2, 3 or 5
Measured: 1-year after randomization
Net adverse clinical events
MACE + bleeding by BARC types 3 or 5
Measured: 1-year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start13 Jan 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University Ilsan Paik Hospital, Seoul St. Mary's Hospital, Mediplex Sejong Hospital, Chonnam National University Hospital, Sejong General Hospital, Wonkwang University Hospital, Gachon University Gil Medical Center, Keimyung University Dongsan Medical Center, Chungbuk National University Hospital, Yeungnam University Hospital, Chungnam National University Hospital, Wonju Severance Christian Hospital, Konkuk University Chungju Hospital, Chung-Ang University Hospital, Dankook University, Incheon St.Mary's Hospital, Gyeongsang National University Hospital, Soonchunhyang University Hospital, Ewha Womans University Seoul Hospital
- Responsible party
- Principal 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
- NCT04014803
- Sponsor's protocol ID
- ATTEMPT16453143
- Acronym
- ATTEMPT
- Status last verified
- Feb 2026
- First submitted
- 8 Jul 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin and a Potent P2Y12 Inhibitor Versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment (SMART-ATTEMPT)
- ClinicalTrials.gov ID
- NCT04014803
- Acronym / sponsor ID
- ATTEMPT / ATTEMPT16453143
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Complex Coronary Lesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Inje University Ilsan Paik Hospital, Seoul St. Mary's Hospital, Mediplex Sejong Hospital, Chonnam National University Hospital, Sejong General Hospital, Wonkwang University Hospital, Gachon University Gil Medical Center, Keimyung University Dongsan Medical Center, Chungbuk National University Hospital, Yeungnam University Hospital, Chungnam National University Hospital, Wonju Severance Christian Hospital, Konkuk University Chungju Hospital, Chung-Ang University Hospital, Dankook University, Incheon St.Mary's Hospital, Gyeongsang National University Hospital, Soonchunhyang University Hospital, Ewha Womans University Seoul Hospital
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jul 2019 (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 evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous coronary intervention with drug eluting stents for complex coronary lesions.
Detailed description
Over the past several decades, dual antiplatelet therapy (DAPT) with the combination of aspirin and a P2Y12 inhibitor has become an essential treatment in patients undergoing percutaneous coronary intervention (PCI) to reduce ischemic events. Although the optimal duration of DAPT still remains controversial in patients with coronary artery disease, the recommended duration of maintenance of DAPT for patients undergoing PCI with drug-eluting stent is ≥12 months for those with acute coronary syndrome (ACS), and ≥6 months for those with stable coronary artery disease according to the current guidelines. However, individualized approach based on ischemic versus bleeding risks assessment is needed to determine the optimal duration of DAPT in various population.
Several studies reported that patients undergoing PCI for complex lesions had significantly higher rates of ischemic events than those with non-complex lesions. Moreover, prolonged DAPT of aspirin and clopidogrel more than 1 year significantly reduced the risk of cardiac ischemic events up to 44% in patients undergoing PCI for complex coronary lesions, and the current guideline recommends prolonged DAPT duration may be considered in patients undergoing complex PCI. Apart from prolonged use of DAPT, use of more potent P2Y12 inhibitor than clopidogrel may be another strategy to reduce ischemic events in patients undergoing PCI for complex coronary lesions. Prasugrel, a new thienopyridine, inhibits platelet aggregation more rapidly and potently than clopidogrel. In the TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel) study, prasugrel reduced ischemic events compared with clopidogrel in patients with acute coronary syndrome. Moreover, low dose prasugrel also reduced ischemic events without an excessive bleeding risk in Japanese population. Therefore, DAPT of aspirin and prasugrel would reduce recurrent ischemic events than DAPT of aspirin and clopidogrel in patients undergoing PCI for complex lesions, a high risk group of ischemic events, even when they do not present with myocardial infarction. So far, there have been no data on this issue.
The aim of the SMART-ATTEMPT (Aspirin and a PoTent P2Y12 inhibitor versus aspirin and clopidogrel Therapy in patients undergoing Elective percutaneous coronary intervention for coMPlex lesion Treatment) trial is to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective PCI for complex lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel plus Aspirin arm | Active comparator | Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirinPatients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of prasugrel 60 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus prasugrel 10 mg once daily* will be given for one year. * Based on previous studies including PRASFIT-ACS (PRASugrel compared with clopidogrel For Japanese patIenTs with ACS undergoing PCI) or TRILOGY ACS (The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes), maintenance dose can be reduced to 5 mg once daily in patients with high bleeding risk or by investigator's medical judgement. |
| Clopidogrel plus Aspirin arm | Active comparator | Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirinPatients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of clopidogrel 600 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for one year. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ① Subject must be at least 19 years of age
- ② Subject who can verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
- ③ Patients undergoing elective PCI as follows:
Key exclusion criteria (11 listed)
- ① Hemodynamic instability or cardiogenic shock
- ② Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.)
- ③ Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke
- ④ Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel)
- ⑤ Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
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 |
|---|---|---|
| Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirinAlso: Prasugrel plus Aspirin or Clopidogrel plus AspirinDual antiplatelet therapy with a P2Y12 inhibitor plus aspirin will be given according to the allocated arms in patients undergoing elective percutaneous coronary intervention for complex coronary lesion 1. Prasugrel plus Aspirin arm 2. Clopidogrel plus Aspirin arm | Drug | Clopidogrel plus Aspirin arm, Prasugrel plus Aspirin arm |
Primary outcome
Major adverse cardiac events (MACE)
Time frame: 1-year after randomization
A composite of death, myocardial infarction, or stent thrombosis
17 secondary outcomes
All-cause death
Time frame: 1-year after randomization
Cardiac death
Time frame: 1-year after randomization
Myocardial infarction
Time frame: 1-year after randomization
Stent thrombosis
Time frame: 1-year after randomization
Target lesion revascularization
Time frame: 1-year after randomization
Target vessel revascularization
Time frame: 1-year after randomization
Any revascularization
Time frame: 1-year after randomization
A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization
Time frame: 1-year after randomization
A composite of all-cause death/myocardial infarction
Time frame: 1-year after randomization
A composite of cardiac death/myocardial infarction
Time frame: 1-year after randomization
Cerebrovascular accident
Time frame: 1-year after randomization
A composite of all-cause death/myocardial infarction/cerebrovascular accident
Time frame: 1-year after randomization
A composite of cardiac death/myocardial infarction/cerebrovascular accident
Time frame: 1-year after randomization
A composite of cardiac death/myocardial infarction/stent thrombosis
Time frame: 1-year after randomization
Bleeding by BARC types 3 or 5
Time frame: 1-year after randomization
Bleeding by BARC types 2, 3, or 5
Time frame: 1-year after randomization
Net adverse clinical events
Time frame: 1-year after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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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.
Joo-Yong Hahn, MD, PhD study chair
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin in people with Coronary Artery Disease, run by Samsung Medical Center at 2 sites 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 12 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joo-Yong Hahn, MD, PhD (82-2-3410-1246, ichjy1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) (time frame: 1-year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2026.