NCT05770674

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,186 (estimated)
• Sponsor: Kiyuk Chang · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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. 1 Month following PCI, followed by clopidogrel monotherapy 2. 12 Months following PCI

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2023-03-15
• Last updated: 2023-03-15

Locations

1 site across 1 country: South Korea