Coronary Artery DiseaseNCT03447379
Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
A study testing P2Y12 antagonist monotherapy and Aspirin plus P2Y12 antagonist in people with Coronary Artery Disease, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®) Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- P2Y12 antagonist monotherapy and Aspirin plus P2Y12 antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,452 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2017to 17 Aug 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19+
- Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
- Patients who understand the content of the subject description and voluntarily sign the subject
Who cannot join
- Age 86+
- Hemodynamically unstable patient
- Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
- Patients at high risk of bleeding, anemia, thrombocytopenia
- Patients requiring oral anticoagulants
- Pregnant women or women of childbearing age
Show all 16Show fewer
- Life expectancy is less than one year
- Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
- Patients with a history of intracranial hemorrhage
- Patients with moderate to severe hepatic impairment
- Patients underwent coronary intervention with stenting within 1 year
- Patients with left-main lesions requiring coronary intervention
- Patients with chronic stricture lesions requiring treatment
- Patients with in-stent restenosis in a lesion requiring treatment
- Patients with bifurcation lesions requiring stenting in lateral branches
- Patients with lesions requiring more than 3 stents
Trial locations and contacts
1 site in 1 country.
About this study
To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)
- Conditions
- Coronary Artery Disease
- Being tested
- P2Y12 antagonist monotherapy, Aspirin plus P2Y12 antagonist
- 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.
P2Y12 antagonist monotherapyDrug
P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day)
Aspirin plus P2Y12 antagonistDrug
DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year
| Study group | Role | What they receive |
|---|---|---|
| P2Y12 antagonist monotherapy | Experimental | P2Y12 antagonist monotherapy after 3-month DAPT Receives: Drug: P2Y12 antagonist monotherapy |
| Aspirin + P2Y12 antagonist | Active comparator | Aspirin + P2Y12 antagonist after 3-month DAPT Receives: Drug: Aspirin plus P2Y12 antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular clinical events (MACCE)
cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization
Measured: between 3 and 12 month after the procedure
Major bleeding
The Bleeding Academic Research Consortium (BARC) type 3 or 5
Measured: between 3 and 12 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start15 Dec 2017
- Primary completion3 Mar 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 1,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bumkee Hong, Gangnam Severance Hospital
- Investigators
- Bumkee Hong, Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447379
- Sponsor's protocol ID
- 3-2017-0230
- Status last verified
- Aug 2022
- First submitted
- 1 Dec 2017
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho S, Chung YH, Min PK, Cho YH, Cheong SS, Kim BK, Lee JH, Kim W, Lee WS, Shin J, Yoon YW, Lee BK, Kang TS, Hong BK; SHARE investigators. P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy by Age After PCI: A SHARE Substudy. JACC Asia. 2026 Oct 14:S2772-3747(26)00801-X. doi: 10.1016/j.jacasi.2026.09.007. Online ahead of print.
PubMed 42886109Min PK, Kang TS, Cho YH, Cheong SS, Kim BK, Kwon SW, Park WJ, Lee JH, Kim W, Lee WS, Yoon YW, Lee BK, Kwon HM, Hong BK; SHARE Investigators. P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e240877. doi: 10.1001/jamanetworkopen.2024.0877.
PubMed 38451525
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
- ClinicalTrials.gov ID
- NCT03447379
- Acronym / sponsor ID
- 3-2017-0230
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,452 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 27 Feb 2018 (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.
To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P2Y12 antagonist monotherapy | Experimental | Drug: P2Y12 antagonist monotherapyP2Y12 antagonist monotherapy after 3-month DAPT |
| Aspirin + P2Y12 antagonist | Active comparator | Drug: Aspirin plus P2Y12 antagonistAspirin + P2Y12 antagonist after 3-month DAPT |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 19+
- Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
- Patients who understand the content of the subject description and voluntarily sign the subject
Key exclusion criteria (16 listed)
- Age 86+
- Hemodynamically unstable patient
- Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
- Patients at high risk of bleeding, anemia, thrombocytopenia
- Patients requiring oral anticoagulants
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 |
|---|---|---|
| P2Y12 antagonist monotherapyP2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) | Drug | P2Y12 antagonist monotherapy |
| Aspirin plus P2Y12 antagonistDAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year | Drug | Aspirin + P2Y12 antagonist |
Primary outcome
Major adverse cardiovascular clinical events (MACCE)
Time frame: between 3 and 12 month after the procedure
cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization
Major bleeding
Time frame: between 3 and 12 month after the procedure
The Bleeding Academic Research Consortium (BARC) type 3 or 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 42886109Cho S, Chung YH, Min PK, Cho YH, Cheong SS, Kim BK, Lee JH, Kim W, Lee WS, Shin J, Yoon YW, Lee BK, Kang TS, Hong BK; SHARE investigators. P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy by Age After PCI: A SHARE Substudy. JACC Asia. 2026 Oct 14:S2772-3747(26)00801-X. doi: 10.1016/j.jacasi.2026.09.007. Online ahead of print.
- Derived from this study: PubMed 38451525Min PK, Kang TS, Cho YH, Cheong SS, Kim BK, Kwon SW, Park WJ, Lee JH, Kim W, Lee WS, Yoon YW, Lee BK, Kwon HM, Hong BK; SHARE Investigators. P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy After Deployment of a Drug-Eluting Stent: The SHARE Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e240877. doi: 10.1001/jamanetworkopen.2024.0877.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Bumkee Hong principal investigator
Gangnam Severance 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 P2Y12 antagonist monotherapy and Aspirin plus P2Y12 antagonist in people with Coronary Artery Disease, run by Gangnam Severance Hospital 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 16 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: finished, as of the sponsor's last update on 12 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular clinical events (MACCE) (time frame: between 3 and 12 month after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447379, which also lists 2 linked publications.
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 12 Mar 2025.