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NCT02939872CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 25 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
238 (actual)
First submitted
18 Oct 2016
Start date
9 Mar 2017
Primary completion date
9 May 2021
Lead sponsor
Seung-Jung Park
NCT number
NCT02939872

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 238
  • From 9 Mar 2017 to the primary completion date, 9 May 2021
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindication to antiplatelet therapy

Other illness

  • 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).

Lab values

  • 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.)

Other

  • Pregnancy test positive (hCG test is performed before randomization in all fertile women)

Who the study is looking for

  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chonnam National University Hospital
Coordinator of this site? Confirm its status
GwangjuSouth KoreaUnknown status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.