- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770674
Comparison of 1 Month vs. 12 Months DAPT in Patients Undergoing PCI With Genoss® DES (GENOSS-DAPT)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul st. mary's hospital
-
Contact:
- Kiyuk Chang
- Phone Number: 82-2-2258-1140
- Email: kiyuk@catholic.ac.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1 Month 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 1 month following PCI.
Following 1 month, clopidogrel 75 mg once daily will be given for 11 months.
|
Dual antiplatelet therapy with aspirin plus clopidogrel will be given for the following period after PCI according to patient allocation
|
Active Comparator: 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.
|
Dual antiplatelet therapy with aspirin plus clopidogrel will be given for the following period after PCI according to patient allocation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NACE (Net Adverse Clinical Event)
Time Frame: 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
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE (Major Adverse Cardiovascular Events)
Time Frame: 12 Months
|
A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, or definite stent thrombosis
|
12 Months
|
BARC Type 3 / 5 bleeding events
Time Frame: 12 Months
|
Bleeding defined by BARC types 3 or 5
|
12 Months
|
All cause death
Time Frame: 12 Months
|
Death by any cause
|
12 Months
|
Cardiovascular death
Time Frame: 12 Months
|
Death by cardiac cause
|
12 Months
|
Myocardial infarction
Time Frame: 12 Months
|
Myocardial infarction
|
12 Months
|
Ischemic or hemorrhagic stroke
Time Frame: 12 Months
|
Ischemic or hemorrhagic stroke
|
12 Months
|
Definite or probable stent thrombosis
Time Frame: 12 Months
|
Definite or probable stent thrombosis
|
12 Months
|
Any revascularization
Time Frame: 12 Months
|
Any repeat revascularization
|
12 Months
|
Ischemia-driven target lesion revascularization
Time Frame: 12 Months
|
Ischemia-driven repeat revascularization of target lesion
|
12 Months
|
BARC Type 2/3/4/5 bleeding
Time Frame: 12 Months
|
Bleeding defined by BARC types 2, 3, 4, or 5
|
12 Months
|
BARC Type 3/4/5 bleeding
Time Frame: 12 Months
|
Bleeding defined by BARC types 3, 4, or 5
|
12 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kiyuk Chang, Seoul st. mary's hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XC21MIDI0023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on 1 Month vs. 12 Months DAPT
-
Yonsei UniversityUnknownCoronary Artery DiseaseKorea, Republic of
-
Kyoto University, Graduate School of MedicineActive, not recruitingCoronary Artery Disease | Acute Coronary Syndrome | Percutaneous Coronary Intervention | Acute Myocardial Infarction | Platelet Aggregation InhibitorsJapan
-
Kyoto University, Graduate School of MedicineActive, not recruitingCoronary Artery DiseaseJapan
-
Shanghai MicroPort Medical (Group) Co., Ltd.RecruitingCoronary Disease | Percutaneous Coronary Intervention | Dual Antiplatelet Therapy | Drug Eluting StentChina
-
China National Center for Cardiovascular DiseasesNot yet recruitingCoronary Artery Disease | Dual Antiplatelet Therapy | Elevated Lipoprotein(a) Level | Drug-Eluting StentChina
-
Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
-
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Memorial Sloan Kettering Cancer CenterWeill Medical College of Cornell University; McMaster UniversityCompleted
-
Hospices Civils de LyonCompleted
-
Northern Arizona UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedMild Traumatic Brain Injury | Concussion | Cognitive Communication DisorderUnited States