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

Coronary Artery Disease Clinical Trial

— GENOSS-DAPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770674
• Other study ID #: XC21MIDI0023
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2186
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (9)

Lead Sponsor	Collaborator
Kiyuk Chang	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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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