An interventional study of 1 Month vs. 12 Months DAPT in Coronary Artery Disease, sponsored by Kiyuk Chang. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by Kiyuk Chang · Not applicable, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 2,186 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Kiyuk Chang is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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. 1 Month following PCI, followed by clopidogrel monotherapy 2. 12 Months following PCI
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
Time frame: 12 Months
MACE (Major Adverse Cardiovascular Events)
A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, or definite stent thrombosis
Time frame: 12 Months
BARC Type 3 / 5 bleeding events
Bleeding defined by BARC types 3 or 5
Time frame: 12 Months
All cause death
Death by any cause
Time frame: 12 Months
Cardiovascular death
Death by cardiac cause
Time frame: 12 Months
Myocardial infarction
Myocardial infarction
Time frame: 12 Months
Ischemic or hemorrhagic stroke
Ischemic or hemorrhagic stroke
Time frame: 12 Months
Definite or probable stent thrombosis
Definite or probable stent thrombosis
Time frame: 12 Months
Any revascularization
Any repeat revascularization
Time frame: 12 Months
Ischemia-driven target lesion revascularization
Ischemia-driven repeat revascularization of target lesion
Time frame: 12 Months
BARC Type 2/3/4/5 bleeding
Bleeding defined by BARC types 2, 3, 4, or 5
Time frame: 12 Months
BARC Type 3/4/5 bleeding
Bleeding defined by BARC types 3, 4, or 5
Time frame: 12 Months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Kiyuk Chang