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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion

Aspirin and a Potent P2Y12 Inhibitor Versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment (SMART-ATTEMPT)

Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion (NCT04014803) is a Phase 4 interventional studying Coronary Artery Disease, sponsored by Samsung Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 3,500 participants makes this one of the larger Coronary Artery Disease trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form prior to any study related procedure - ③ Patients undergoing elective PCI as follows: 1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size 2. Chronic total occlusion (≥3 months) as target lesion 3. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions) 4. Long coronary lesions (expected stent length ≥38 mm) 5. Multi-vessel PCI (≥2 vessels treated at one PCI session) 6. Multiple stent needed (≥3 stents per patient) 7. In-stent restenosis lesion as target lesion 8. Severely calcified lesion (encircling calcium in angiography) 9. Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery Who Should NOT Join This Trial: - 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) - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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: 1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size 2. Chronic total occlusion (≥3 months) as target lesion 3. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions) 4. Long coronary lesions (expected stent length ≥38 mm) 5. Multi-vessel PCI (≥2 vessels treated at one PCI session) 6. Multiple stent needed (≥3 stents per patient) 7. In-stent restenosis lesion as target lesion 8. Severely calcified lesion (encircling calcium in angiography) 9. Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery Exclusion Criteria: * 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) * 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.

Treatments Being Tested

DRUG

Dual antiplatelet therapy with a P2Y12 inhibitor 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 1. Prasugrel plus Aspirin arm 2. Clopidogrel plus Aspirin arm

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Samsung Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04014803), the sponsor (Samsung Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04014803 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04014803?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04014803?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04014803. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04014803. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.