Back to resultsShort-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
Primary Purpose
Coronary Artery Disease
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
P2Y12 antagonist monotherapy
Aspirin plus P2Y12 antagonist
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Gangnam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
P2Y12 antagonist monotherapy
Aspirin + P2Y12 antagonist
Arm Description
P2Y12 antagonist monotherapy after 3-month DAPT
Aspirin + P2Y12 antagonist after 3-month DAPT
Outcomes
Primary Outcome Measures
Major adverse cardiovascular clinical events (MACCE)
cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization
Major bleeding
The Bleeding Academic Research Consortium (BARC) type 3 or 5
Secondary Outcome Measures
Full Information
NCT ID
NCT03447379
First Posted
December 1, 2017
Last Updated
September 14, 2022
Sponsor
Gangnam Severance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03447379
Brief Title
Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
Official Title
Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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®)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1452 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
P2Y12 antagonist monotherapy
Arm Type
Experimental
Arm Description
P2Y12 antagonist monotherapy after 3-month DAPT
Arm Title
Aspirin + P2Y12 antagonist
Arm Type
Active Comparator
Arm Description
Aspirin + P2Y12 antagonist after 3-month DAPT
Intervention Type
Drug
Intervention Name(s)
P2Y12 antagonist monotherapy
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Aspirin plus P2Y12 antagonist
Intervention Description
DAPT(Aspirin 100mg/day + Clopidogrel 75mg/day or Aspirin 100mg/day + Ticagrelor 180mg/day) for a year
Primary Outcome Measure Information:
Title
Major adverse cardiovascular clinical events (MACCE)
Description
cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization
Time Frame
between 3 and 12 month after the procedure
Title
Major bleeding
Description
The Bleeding Academic Research Consortium (BARC) type 3 or 5
Time Frame
between 3 and 12 month after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bumkee Hong
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
State/Province
Souel
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
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