Clinical trial NCT05770674: Comparison of 1 Month vs. 12 Months DAPT in Patients Undergoing PCI With Genoss® DES
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous Coronary Intervention
Dual Antiplatelet Therapy
Drug Eluting Stent
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Uijeongbu St. Mary Hospital
name: St Vincent's Hospital
name: Bucheon St. Mary's Hospital
name: Wonju Severance Christian Hospital
name: Chungbuk National University Hospital
name: Daejeon St. Mary's hospital
name: Korea University Guro Hospital
name: Seoul St. Mary's Hospital
First posted: 2023-03-15
Enrollment: 2186
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: NACE (Net Adverse Clinical Event)
timeFrame: 12 Months
Secondary outcomes:
measure: MACE (Major Adverse Cardiovascular Events)
timeFrame: 12 Months
measure: BARC Type 3 / 5 bleeding events
timeFrame: 12 Months
measure: All cause death
timeFrame: 12 Months
measure: Cardiovascular death
timeFrame: 12 Months
measure: Myocardial infarction
timeFrame: 12 Months
measure: Ischemic or hemorrhagic stroke
timeFrame: 12 Months
measure: Definite or probable stent thrombosis
timeFrame: 12 Months
measure: Any revascularization
timeFrame: 12 Months
measure: Ischemia-driven target lesion revascularization
timeFrame: 12 Months
measure: BARC Type 2/3/4/5 bleeding
timeFrame: 12 Months
measure: BARC Type 3/4/5 bleeding
timeFrame: 12 Months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Kiyuk Chang
role: PRINCIPAL_INVESTIGATOR
References: