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

Study Overview
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Brief Summary
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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.

Detailed Description
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Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended following percutaneous coronary intervention (PCI). However, the optimal duration of DAPT is still controversial, and current US and European guidelines recommend 12+ months for Acute Coronary Syndrome (ACS) and 6+ months in Chronic Coronary Syndrome (CCS). A meta-analysis comparing short (6 months) and long-term (12 months) DAPT has shown a lower risk of bleeding with no significant increase in ischemia risk associated with short DAPT use. Monotherapy with a P2Y12 inhibitor clopidogrel has been proposed as a novel alternative to DAPT in patients with atherosclerotic cardiovascular disease. Clopidogrel has shown comparable bleeding events after PCI compared to aspirin, and reduced the risk of subsequent ischemic events. In addition, several trials have reported that clopidogrel monotherapy now has a lower risk of bleeding than antiplatelet drug therapy (DAPT). These results suggest that P2Y12 inhibitor monotherapy has a lower risk of bleeding in patients with PCI and can be compared with DAPT in preventing recurrent ischemic events. Given that Genoss® Drug-Eluting Stent (DES) has a very low incidence of Stent Thrombosis (ST), short-term DAPT after PCI is now expected to reduce the risk of bleeding with clopidogrel instead of aspirin, without increasing cardiovascular events.

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: 1 Month vs. 12 Months DAPT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Month DAPT<br>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. | Drug: 1 Month vs. 12 Months DAPT<br>* Dual antiplatelet therapy with aspirin plus clopidogrel will be given for the following period after PCI according to patient allocation 1 Month following PCI, followed by clopidogrel monotherapy 12 Months following PCI<br>|
| Active Comparator: 12 Months DAPT<br>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. | Drug: 1 Month vs. 12 Months DAPT<br>* Dual antiplatelet therapy with aspirin plus clopidogrel will be given for the following period after PCI according to patient allocation 1 Month following PCI, followed by clopidogrel monotherapy 12 Months following PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NACE (Net Adverse Clinical Event) | A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, definite stent thrombosis, or BARC (Bleeding Academic Research Consortium) type 3 or 5 bleeding events | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (Major Adverse Cardiovascular Events) | A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, or definite stent thrombosis | 12 Months | 
| BARC Type 3 / 5 bleeding events | Bleeding defined by BARC types 3 or 5 | 12 Months | 
| All cause death | Death by any cause | 12 Months | 
| Cardiovascular death | Death by cardiac cause | 12 Months | 
| Myocardial infarction | Myocardial infarction | 12 Months | 
| Ischemic or hemorrhagic stroke | Ischemic or hemorrhagic stroke | 12 Months | 
| Definite or probable stent thrombosis | Definite or probable stent thrombosis | 12 Months | 
| Any revascularization | Any repeat revascularization | 12 Months | 
| Ischemia-driven target lesion revascularization | Ischemia-driven repeat revascularization of target lesion | 12 Months | 
| BARC Type 2/3/4/5 bleeding | Bleeding defined by BARC types 2, 3, 4, or 5 | 12 Months | 
| BARC Type 3/4/5 bleeding | Bleeding defined by BARC types 3, 4, or 5 | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Drug Eluting Stent