Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events

Study Overview
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Brief Summary
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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.

Official Title
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Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial

Conditions
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Percutaneous Transluminal Coronary Angioplasty, Coronary Disease

Intervention / Treatment
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* Drug: aspirin and clopidogrel
* Drug: Clopidogrel only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAPT<br>Dual antiplatelet therapy : aspirin and clopidogrel | Drug: aspirin and clopidogrel<br>* at the discretion of investigator<br>|
| Active Comparator: Clopidogrel only<br>Clopidogrel monotherapy | Drug: Clopidogrel only<br>* at the discretion of investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite event of death, myocardial infarction, or stroke |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | all cause death or cardiac death | 5 years | 
| Myocardial Infarction |  | 5 years | 
| Stroke | cerebral ischemic or hemorrhage | 5 years | 
| Target Vessel Revascularization |  | 5 years | 
| Target Lesion Revascularization |  | 5 years | 
| Stent thrombosis |  | 5 years | 
| Bleeding |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAPT, BVS, Bioresorbable Vascular Scaffold, Dual Antiplatelet Therapy