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OpenTrials
Completed

NCT Number: NCT02939872

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center, Seoul, Songpa-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aspirin and clopidogrel

Drug

at the discretion of investigator

Clopidogrel only

Drug

at the discretion of investigator

Primary outcomes

  1. composite event of death, myocardial infarction, or stroke

    Time frame: 1 year

Secondary outcomes

  1. Death

    Time frame: 5 years

    all cause death or cardiac death

  2. Myocardial Infarction

    Time frame: 5 years

  3. Stroke

    Time frame: 5 years

    cerebral ischemic or hemorrhage

  4. Target Vessel Revascularization

    Time frame: 5 years

  5. Target Lesion Revascularization

    Time frame: 5 years

  6. Stent thrombosis

    Time frame: 5 years

  7. Bleeding

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: BVS LATE

Important dates

Study start
2017
Primary completion
2021
Study completion
2024
First posted
Oct 20, 2016
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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