NCT04014803RecruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 3500 (estimated)
- First submitted
- 8 Jul 2019
- Start date
- 13 Jan 2020
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT04014803
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 3500
- From 13 Jan 2020 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ③ Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke
Other illness
- ② Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.)
- ④ Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel)
- 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
- 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.
Age
- ⑨ Subjects ≥75 years of age or \<60 kg of body weight
Other
- ① Hemodynamic instability or cardiogenic shock
- 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
- ⑧ Patients chronically taking prasugrel or ticagrelor (≥1 week)
Who the study is looking for
- 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)
- 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
Age in the registry: 19 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.