Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events
BVS LATE
1 other identifier
interventional
238
1 country
2
Brief Summary
The purpose of this study is to evaluate optimal duration of antiplatelet therapy after Bioresorbable Vascular Scaffold implantation to reduce late coronary arterial thrombotic events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2017
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 20, 2016
CompletedStudy Start
First participant enrolled
March 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2024
CompletedJune 25, 2024
June 1, 2024
4.2 years
October 18, 2016
June 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite event of death, myocardial infarction, or stroke
1 year
Secondary Outcomes (7)
Death
5 years
Myocardial Infarction
5 years
Stroke
5 years
Target Vessel Revascularization
5 years
Target Lesion Revascularization
5 years
- +2 more secondary outcomes
Study Arms (2)
DAPT
EXPERIMENTALDual antiplatelet therapy : aspirin and clopidogrel
Clopidogrel only
ACTIVE COMPARATORClopidogrel monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Men or women at least 19 years of age
- Patients undergoing dual- or triple-antiplatelet therapy at least 12-14 months after PCI with BVS
- Among the participants underwent PCI with BVS, event-free patients who survived the first 12 months without death, serious MI, stroke, repeat revascularization or major bleeding (except non-significant peri-procedural MI)
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
You may not qualify if:
- Contraindication to antiplatelet therapy
- If the physician believes that the patient need continuation of dual anti-platelet therapy because of comorbidities (ACS, peripheral vascular disease, significant carotid disease, etc.)
- Continuous administration of clopidogrel is impossible due to comorbidities of the patient (major bleeding history, bleeding diathesis)
- Cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Pregnancy test positive (hCG test is performed before randomization in all fertile women)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (2)
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Chonnam National University Hospital
Gwangju, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor, Division of Cardiology, Department of Internal Medicine
Study Record Dates
First Submitted
October 18, 2016
First Posted
October 20, 2016
Study Start
March 9, 2017
Primary Completion
May 9, 2021
Study Completion
June 3, 2024
Last Updated
June 25, 2024
Record last verified: 2024-06