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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: 1 Month vs. 12 Months DAPT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul St. Mary'S Hospital
    • Contact: Kiyuk Chang; Phone Number: 82-2-2258-1140; Email: kiyuk@catholic.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 1 Month vs. 12 Months DAPT; 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
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.	Drug: 1 Month vs. 12 Months DAPT; 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Drug Eluting Stent; Dual Antiplatelet Therapy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: XC21MIDI0023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No