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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
1 Month vs. 12 Months DAPT
Sponsored by
Kiyuk Chang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Drug Eluting Stent

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 Month DAPT

12 Months DAPT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MACE (Major Adverse Cardiovascular Events)
A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, or definite stent thrombosis
BARC Type 3 / 5 bleeding events
Bleeding defined by BARC types 3 or 5
All cause death
Death by any cause
Cardiovascular death
Death by cardiac cause
Myocardial infarction
Myocardial infarction
Ischemic or hemorrhagic stroke
Ischemic or hemorrhagic stroke
Definite or probable stent thrombosis
Definite or probable stent thrombosis
Any revascularization
Any repeat revascularization
Ischemia-driven target lesion revascularization
Ischemia-driven repeat revascularization of target lesion
BARC Type 2/3/4/5 bleeding
Bleeding defined by BARC types 2, 3, 4, or 5
BARC Type 3/4/5 bleeding
Bleeding defined by BARC types 3, 4, or 5

Full Information

First Posted
March 5, 2023
Last Updated
March 5, 2023
Sponsor
Kiyuk Chang
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05770674
Brief Title
Comparison of 1 Month vs. 12 Months DAPT in Patients Undergoing PCI With Genoss® DES
Acronym
GENOSS-DAPT
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kiyuk Chang
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Drug Eluting Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 Month DAPT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
12 Months DAPT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
1 Month vs. 12 Months DAPT
Intervention Description
Dual antiplatelet therapy with aspirin plus clopidogrel will be given for the following period after PCI according to patient allocation 1 Month following PCI, followed by clopidogrel monotherapy 12 Months following PCI
Primary Outcome Measure Information:
Title
NACE (Net Adverse Clinical Event)
Description
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
Secondary Outcome Measure Information:
Title
MACE (Major Adverse Cardiovascular Events)
Description
A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, or definite stent thrombosis
Time Frame
12 Months
Title
BARC Type 3 / 5 bleeding events
Description
Bleeding defined by BARC types 3 or 5
Time Frame
12 Months
Title
All cause death
Description
Death by any cause
Time Frame
12 Months
Title
Cardiovascular death
Description
Death by cardiac cause
Time Frame
12 Months
Title
Myocardial infarction
Description
Myocardial infarction
Time Frame
12 Months
Title
Ischemic or hemorrhagic stroke
Description
Ischemic or hemorrhagic stroke
Time Frame
12 Months
Title
Definite or probable stent thrombosis
Description
Definite or probable stent thrombosis
Time Frame
12 Months
Title
Any revascularization
Description
Any repeat revascularization
Time Frame
12 Months
Title
Ischemia-driven target lesion revascularization
Description
Ischemia-driven repeat revascularization of target lesion
Time Frame
12 Months
Title
BARC Type 2/3/4/5 bleeding
Description
Bleeding defined by BARC types 2, 3, 4, or 5
Time Frame
12 Months
Title
BARC Type 3/4/5 bleeding
Description
Bleeding defined by BARC types 3, 4, or 5
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiyuk Chang
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyuk Chang
Phone
82-2-2258-1140
Email
kiyuk@catholic.ac.kr

12. IPD Sharing Statement

Learn more about this trial

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

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