Coronary Artery DiseaseGENOSS-DAPTNCT05770674
Comparison of 1 Month vs. 12 Months DAPT in Patients Undergoing PCI With Genoss® DES
A study testing 1 Month vs. 12 Months DAPT in people with Coronary Artery Disease, run by Kiyuk Chang at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 1 Month vs. 12 Months DAPT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,186 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul
Kiyuk Chang, 82-2-2258-1140, kiyuk@catholic.ac.kr
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- 1 Month vs. 12 Months DAPT
- Keywords
- Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Drug Eluting Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Month vs. 12 Months DAPTDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 Month DAPT | Active comparator | 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. Receives: Drug: 1 Month vs. 12 Months DAPT |
| 12 Months DAPT | Active comparator | 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. Receives: Drug: 1 Month vs. 12 Months DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Secondary outcomes (11)
MACE (Major Adverse Cardiovascular Events)
A composite of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, or definite stent thrombosis
Measured: 12 Months
BARC Type 3 / 5 bleeding events
Bleeding defined by BARC types 3 or 5
Measured: 12 Months
All cause death
Death by any cause
Measured: 12 Months
Cardiovascular death
Death by cardiac cause
Measured: 12 Months
Myocardial infarction
Myocardial infarction
Measured: 12 Months
Ischemic or hemorrhagic stroke
Ischemic or hemorrhagic stroke
Measured: 12 Months
Definite or probable stent thrombosis
Definite or probable stent thrombosis
Measured: 12 Months
Any revascularization
Any repeat revascularization
Measured: 12 Months
Ischemia-driven target lesion revascularization
Ischemia-driven repeat revascularization of target lesion
Measured: 12 Months
BARC Type 2/3/4/5 bleeding
Bleeding defined by BARC types 2, 3, 4, or 5
Measured: 12 Months
BARC Type 3/4/5 bleeding
Bleeding defined by BARC types 3, 4, or 5
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Apr 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiyuk Chang
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Kiyuk Chang, Seoul St. Mary's Hospital
- Investigators
- Kiyuk Chang, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770674
- Sponsor's protocol ID
- XC21MIDI0023
- Acronym
- GENOSS-DAPT
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05770674
- Acronym / sponsor ID
- GENOSS-DAPT / XC21MIDI0023
- Conditions
- Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Drug Eluting Stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,186 participants (estimated)
- Lead sponsor
- Kiyuk ChangUniversity, hospital or other
- 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
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Month DAPT | Active comparator | Drug: 1 Month vs. 12 Months DAPTPatients 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. |
| 12 Months DAPT | Active comparator | Drug: 1 Month vs. 12 Months DAPTPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 Month vs. 12 Months DAPTDual 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 | Drug | 1 Month DAPT, 12 Months DAPT |
Primary outcome
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
11 secondary outcomes
MACE (Major Adverse Cardiovascular Events)
Time frame: 12 Months
BARC Type 3 / 5 bleeding events
Time frame: 12 Months
All cause death
Time frame: 12 Months
Cardiovascular death
Time frame: 12 Months
Myocardial infarction
Time frame: 12 Months
Ischemic or hemorrhagic stroke
Time frame: 12 Months
Definite or probable stent thrombosis
Time frame: 12 Months
Any revascularization
Time frame: 12 Months
Ischemia-driven target lesion revascularization
Time frame: 12 Months
BARC Type 2/3/4/5 bleeding
Time frame: 12 Months
BARC Type 3/4/5 bleeding
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiyuk Chang principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Month vs. 12 Months DAPT in people with Coronary Artery Disease, run by Kiyuk Chang at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NACE (Net Adverse Clinical Event) (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.