NCT04014803 Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion
| NCT ID | NCT04014803 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Samsung Medical Center |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,500 participants |
| Start Date | 2020-01-13 |
| Primary Completion | 2027-06-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility 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 Cri