Comparing two treatments for patients with complex coronary lesions undergoing PCI
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 testing whether using aspirin with prasugrel or aspirin with clopidogrel is better for people with complex heart issues who are having a procedure to open blocked arteries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3500 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT04014803 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of dual antiplatelet therapy using aspirin combined with prasugrel versus aspirin combined with clopidogrel in patients undergoing elective percutaneous coronary intervention (PCI) for complex coronary lesions. It is a prospective, open-label, two-arm, randomized multicenter trial aimed at reducing ischemic events in this high-risk population. The study will assess the optimal duration of treatment and the potential benefits of using a more potent P2Y12 inhibitor in conjunction with aspirin. Participants will be monitored for ischemic events and safety outcomes over the course of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 19 and older undergoing elective PCI for complex coronary lesions.
Not a fit: Patients with non-complex coronary lesions or those not undergoing PCI may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that significantly reduce the risk of ischemic events in patients with complex coronary lesions.
How similar studies have performed: Other studies have shown promising results with similar dual antiplatelet therapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Seoul and 1 other locations
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Joo-Yong Hahn, MD, PhD
- Email: ichjy1@gmail.com
- Phone: 82-2-3410-1246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.