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

NCT ID: NCT05770674

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-12-31

Brief 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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

1 Month vs. 12 Months DAPT

Intervention Type: DRUG

Dual antiplatelet therapy with aspirin plus clopidogrel will be given for the following period after PCI according to patient allocation

1. 1 Month following PCI, followed by clopidogrel monotherapy

2. 12 Months following PCI

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.

Group Type: ACTIVE_COMPARATOR

1 Month vs. 12 Months DAPT

Intervention Type: DRUG

Dual antiplatelet therapy with aspirin plus clopidogrel will be given for the following period after PCI according to patient allocation

1. 1 Month following PCI, followed by clopidogrel monotherapy

2. 12 Months following PCI

Interventions

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. 1 Month following PCI, followed by clopidogrel monotherapy

2. 12 Months following PCI

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uijeongbu St. Mary Hospital

OTHER

Sponsor Role: collaborator

St Vincent's Hospital

OTHER

Sponsor Role: collaborator

Bucheon St. Mary's Hospital

OTHER

Sponsor Role: collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role: collaborator

Chungbuk National University Hospital

OTHER

Sponsor Role: collaborator

Daejeon St. Mary's hospital

OTHER

Sponsor Role: collaborator

Korea University Guro Hospital

OTHER

Sponsor Role: collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role: collaborator

Kiyuk Chang

OTHER

Sponsor Role: lead

Responsible Party

Kiyuk Chang

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kiyuk Chang

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Kiyuk Chang

Role: primary

kiyuk@catholic.ac.kr

82-2-2258-1140

Other Identifiers

XC21MIDI0023

Identifier Type: -

Identifier Source: org_study_id