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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborators: Chonnam National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Chungbuk National University Hospital; Chungnam National University Hospital; Dankook University; Ewha Womans University; Ewha Womans University Seoul Hospital; Gachon University Gil Medical Center; Gyeongsang National University Hospital; Incheon St.Mary's Hospital; Inje University; Keimyung University Dongsan Medical Center; Konkuk University Chungju Hospital; Mediplex Sejong Hospital; Sejong General Hospital; Seoul St. Mary's Hospital; Soonchunhyang University Hospital; Wonju Severance Christian Hospital; Wonkwang University Hospital; Yeungnam University Hospital
• Treatments: Aspirin; Clopidogrel; Prasugrel Hydrochloride

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.