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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02939872
Recruitment Status : Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : June 23, 2021
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE October 20, 2016
Last Update Posted Date June 23, 2021
Actual Study Start Date  ICMJE March 9, 2017
Actual Primary Completion Date May 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
composite event of death, myocardial infarction, or stroke [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
  • Death [ Time Frame: 5 years ]
    all cause death or cardiac death
  • Myocardial Infarction [ Time Frame: 5 years ]
  • Stroke [ Time Frame: 5 years ]
    cerebral ischemic or hemorrhage
  • Target Vessel Revascularization [ Time Frame: 5 years ]
  • Target Lesion Revascularization [ Time Frame: 5 years ]
  • Stent thrombosis [ Time Frame: 5 years ]
  • Bleeding [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events
Official Title  ICMJE Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Percutaneous Transluminal Coronary Angioplasty
  • Coronary Disease
Intervention  ICMJE
  • Drug: aspirin and clopidogrel
    at the discretion of investigator
  • Drug: Clopidogrel only
    at the discretion of investigator
Study Arms  ICMJE
  • Experimental: DAPT
    Dual antiplatelet therapy : aspirin and clopidogrel
    Intervention: Drug: aspirin and clopidogrel
  • Active Comparator: Clopidogrel only
    Clopidogrel monotherapy
    Intervention: Drug: Clopidogrel only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 24, 2019)
238
Original Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
2000
Estimated Study Completion Date  ICMJE June 30, 2024
Actual Primary Completion Date May 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 19 and more
  • On dual or triple antiplatelet therapy and between 12months and 14months from Bioresorbable Vascular Scaffold implantation
  • No history of death, serious myocardial infarction, stroke, repeat revascularization, or major bleeding

Exclusion Criteria:

  • Contraindication to antiplatelet therapy
  • Need to continue clopidogrel due to stroke, peripheral disease, significant carotid disease or recent acute coronary syndrome
  • Major bleeding history or bleeding diathesis
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939872
Other Study ID Numbers  ICMJE AMCCV2016-23
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Seung-Jung Park, Asan Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Seung-Jung Park
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE CardioVascular Research Foundation, Korea
Investigators  ICMJE Not Provided
PRS Account Asan Medical Center
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP