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Clinical Trials/NCT02939872
NCT02939872CompletedPhase 4

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

Seung-Jung Park2 sites in 1 country238 target enrollmentStarted: March 9, 2017Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
238
Locations
2
Primary Endpoint
composite event of death, myocardial infarction, or stroke
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

DAPT

Experimental

Dual antiplatelet therapy : aspirin and clopidogrel

Intervention: aspirin and clopidogrel (Drug)

Clopidogrel only

Active Comparator

Clopidogrel monotherapy

Intervention: Clopidogrel only (Drug)

Outcomes

Primary Outcomes

composite event of death, myocardial infarction, or stroke

Time Frame: 1 year

Secondary Outcomes

  • Target Lesion Revascularization(5 years)
  • Stent thrombosis(5 years)
  • Bleeding(5 years)
  • Death(5 years)
  • Myocardial Infarction(5 years)
  • Stroke(5 years)
  • Target Vessel Revascularization(5 years)

Investigators

Sponsor
Seung-Jung Park
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Seung-Jung Park

professor, Division of Cardiology, Department of Internal Medicine

Asan Medical Center

Study Sites (2)

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