Back to resultsOptimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events (BVS LATE)
Primary Purpose
Percutaneous Transluminal Coronary Angioplasty, Coronary Disease
Status
Active
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
aspirin and clopidogrel
Clopidogrel only
Sponsored by
About this trial
This is an interventional treatment trial for Percutaneous Transluminal Coronary Angioplasty focused on measuring DAPT, BVS, Bioresorbable Vascular Scaffold, Dual Antiplatelet Therapy
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
- Chonnam National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DAPT
Clopidogrel only
Arm Description
Dual antiplatelet therapy : aspirin and clopidogrel
Clopidogrel monotherapy
Outcomes
Primary Outcome Measures
composite event of death, myocardial infarction, or stroke
Secondary Outcome Measures
Death
all cause death or cardiac death
Myocardial Infarction
Stroke
cerebral ischemic or hemorrhage
Target Vessel Revascularization
Target Lesion Revascularization
Stent thrombosis
Bleeding
Full Information
NCT ID
NCT02939872
First Posted
October 18, 2016
Last Updated
July 7, 2022
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02939872
Brief Title
Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events
Acronym
BVS LATE
Official Title
Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 9, 2017 (Actual)
Primary Completion Date
May 9, 2021 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Transluminal Coronary Angioplasty, Coronary Disease
Keywords
DAPT, BVS, Bioresorbable Vascular Scaffold, Dual Antiplatelet Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAPT
Arm Type
Experimental
Arm Description
Dual antiplatelet therapy : aspirin and clopidogrel
Arm Title
Clopidogrel only
Arm Type
Active Comparator
Arm Description
Clopidogrel monotherapy
Intervention Type
Drug
Intervention Name(s)
aspirin and clopidogrel
Intervention Description
at the discretion of investigator
Intervention Type
Drug
Intervention Name(s)
Clopidogrel only
Intervention Description
at the discretion of investigator
Primary Outcome Measure Information:
Title
composite event of death, myocardial infarction, or stroke
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Death
Description
all cause death or cardiac death
Time Frame
5 years
Title
Myocardial Infarction
Time Frame
5 years
Title
Stroke
Description
cerebral ischemic or hemorrhage
Time Frame
5 years
Title
Target Vessel Revascularization
Time Frame
5 years
Title
Target Lesion Revascularization
Time Frame
5 years
Title
Stent thrombosis
Time Frame
5 years
Title
Bleeding
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events
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