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

Kiyuk Chang

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Drug: 1 Month vs. 12 Months DAPT

Study type: Interventional

Funder types: Other

Identifiers

NCT05770674

XC21MIDI0023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,186 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,186 participants in 2 patient groups

1 Month DAPT

Active Comparator group

Description:

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.

Treatment:

Drug: 1 Month vs. 12 Months DAPT

12 Months DAPT

Active Comparator group

Description:

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.

Treatment:

Drug: 1 Month vs. 12 Months DAPT