Coronary Artery Disease
Conditions
Keywords
Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Drug Eluting Stent
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.
Interventions
DRUG1 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
Sponsors
Uijeongbu St. Mary Hospital
St Vincent's Hospital
Bucheon St. Mary's Hospital
Wonju Severance Christian Hospital
Chungbuk National University Hospital
Daejeon St. Mary's hospital
Korea University Guro Hospital
Seoul St. Mary's Hospital
Kiyuk Chang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NACE (Net Adverse Clinical Event) | 12 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infarction | 12 Months | Myocardial infarction |
| Ischemic or hemorrhagic stroke | 12 Months | Ischemic or hemorrhagic stroke |
| MACE (Major Adverse Cardiovascular Events) | 12 Months | A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, or definite stent thrombosis |
| BARC Type 3 / 5 bleeding events | 12 Months | Bleeding defined by BARC types 3 or 5 |
| All cause death | 12 Months | Death by any cause |
| Cardiovascular death | 12 Months | Death by cardiac cause |
| Any revascularization | 12 Months | Any repeat revascularization |
| Ischemia-driven target lesion revascularization | 12 Months | Ischemia-driven repeat revascularization of target lesion |
| BARC Type 2/3/4/5 bleeding | 12 Months | Bleeding defined by BARC types 2, 3, 4, or 5 |
| BARC Type 3/4/5 bleeding | 12 Months | Bleeding defined by BARC types 3, 4, or 5 |
| Definite or probable stent thrombosis | 12 Months | Definite or probable stent thrombosis |
Countries
South Korea
Outcome results
None listed