Prospective, Open-label, Multicenter, Randomized Clinical Trial Comparing 1 Month vs. 12 Months Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention With Genoss® Drug Eluting Stent
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
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• 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
Locations
Other Locations
Republic of Korea
Seoul St. Mary's Hospital
RECRUITING
Seoul
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 2186
Treatments
Active_comparator: 1 Month DAPT
Patients will receive 300 mg of aspirin and 300 mg of clopidogrel before PCI unless previously medicated with antiplatelet agents. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for 1 month following PCI. Following 1 month, clopidogrel 75 mg once daily will be given for 11 months.
Active_comparator: 12 Months DAPT
Patients will receive 300 mg of aspirin and 300 mg of clopidogrel before PCI unless previously medicated with antiplatelet agents. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for 12 months following PCI.
Related Therapeutic Areas
Sponsors
Collaborators: Daejeon St. Mary's hospital, St Vincent's Hospital, Bucheon St. Mary's Hospital, Chungbuk National University Hospital, Korea University Guro Hospital, Seoul St. Mary's Hospital, Uijeongbu St. Mary Hospital, Wonju Severance Christian Hospital
Leads: Kiyuk Chang