Percutaneous Transluminal Coronary Angioplasty, Coronary Disease
Conditions
Keywords
DAPT, BVS, Bioresorbable Vascular Scaffold, Dual Antiplatelet Therapy
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.
Interventions
at the discretion of investigator
DRUGClopidogrel only
at the discretion of investigator
Sponsors
CardioVascular Research Foundation, Korea
Seung-Jung Park
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men or women at least 19 years of age 2. Patients undergoing dual- or triple-antiplatelet therapy at least 12-14 months after PCI with BVS 3. 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) 4. 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.
Exclusion criteria
1. Contraindication to antiplatelet therapy 2. 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.) 3. Continuous administration of clopidogrel is impossible due to comorbidities of the patient (major bleeding history, bleeding diathesis) 4. 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). 5. Pregnancy test positive (hCG test is performed before randomization in all fertile women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite event of death, myocardial infarction, or stroke | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Infarction | 5 years | — |
| Stroke | 5 years | cerebral ischemic or hemorrhage |
| Target Vessel Revascularization | 5 years | — |
| Death | 5 years | all cause death or cardiac death |
| Stent thrombosis | 5 years | — |
| Bleeding | 5 years | — |
| Target Lesion Revascularization | 5 years | — |
Countries
South Korea
Outcome results
None listed