Comparison of 1 Month vs. 12 Months DAPT in Patients Undergoing PCI With Genoss® DES

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective, open-label, multicenter, randomized clinical trial to evaluate the efficacy of 1 month dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel followed by clopidogrel monotherapy, compared with 12 months DAPT with aspirin plus clopidogrel in patients undergoing percutaneous coronary intervention with Genoss® drug eluting stents.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kiyuk Chang
• Collaborators: Bucheon St. Mary's Hospital; Chungbuk National University Hospital; Daejeon St. Mary's hospital; Korea University Guro Hospital; Seoul St. Mary's Hospital; St Vincent's Hospital; Uijeongbu St. Mary Hospital; Wonju Severance Christian Hospital

Criteria

Inclusion Criteria:

• Subjects must be at least 19 years of age

• Subjects undergoing elective PCI with Genoss® Drug Eluting Stents

• Subject who can understand the risk, benefit and treatment alternatives, and when he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

Exclusion Criteria:

• Subjects presenting with acute myocardial infarction

• Subjects with less than 1 year of life expectancy

• Subjects presenting with cardiogenic shock

• Subjects requiring anticoagulation (warfarin, direct oral anticoagulant), or those requiring antiplatelet agents other than aspirin and P2Y12 inhibitors.

• Subjects with history of intracranial hemorrhage (ICH)

• Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel), or drugs used in the procedure (heparin, contrast media, sirolimus). Those with contrast hypersensitivity can be enrolled if symptom/signs can be controlled by anti-histamines or steroids.