Percutaneous Transluminal Coronary AngioplastyPhase 4BVS LATENCT02939872
Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events
A Phase 4 study testing aspirin and clopidogrel and Clopidogrel only in people with Percutaneous Transluminal Coronary Angioplasty and Coronary Disease, run by Seung-Jung Park at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Percutaneous Transluminal Coronary Angioplasty, Coronary Disease
- What is being tested?
- aspirin and clopidogrel and Clopidogrel only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 9 Mar 2017to 3 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chonnam National University Hospital
Gwangju
Asan Medical Center
Seoul, Songpa-gu, 138-736
About this study
Official title: Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial
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.
- Being tested
- aspirin and clopidogrel, Clopidogrel only
- Keywords
- DAPT, BVS, Bioresorbable Vascular Scaffold, Dual Antiplatelet Therapy
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin and clopidogrelDrug
at the discretion of investigator
Clopidogrel onlyDrug
at the discretion of investigator
| Study group | Role | What they receive |
|---|---|---|
| DAPT | Experimental | Dual antiplatelet therapy : aspirin and clopidogrel Receives: Drug: aspirin and clopidogrel |
| Clopidogrel only | Active comparator | Clopidogrel monotherapy Receives: Drug: Clopidogrel only |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite event of death, myocardial infarction, or stroke
Measured: 1 year
Secondary outcomes (7)
Death
all cause death or cardiac death
Measured: 5 years
Myocardial Infarction
Measured: 5 years
Stroke
cerebral ischemic or hemorrhage
Measured: 5 years
Target Vessel Revascularization
Measured: 5 years
Target Lesion Revascularization
Measured: 5 years
Stent thrombosis
Measured: 5 years
Bleeding
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start9 Mar 2017
- Primary completion9 May 2021
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Transluminal Coronary AngioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939872
- Sponsor's protocol ID
- AMCCV2016-23
- Acronym
- BVS LATE
- Status last verified
- Jun 2024
- First submitted
- 18 Oct 2016
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Antiplatelet Therapy After Bioresorbable Vascular Scaffold Implantation to Reduce Late Coronary Arterial Thrombotic Events: BVS-LATE Trial
- ClinicalTrials.gov ID
- NCT02939872
- Acronym / sponsor ID
- BVS LATE / AMCCV2016-23
- Keywords
- DAPT, BVS, Bioresorbable Vascular Scaffold, Dual Antiplatelet Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 9 May 2021 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAPT | Experimental | Drug: aspirin and clopidogrelDual antiplatelet therapy : aspirin and clopidogrel |
| Clopidogrel only | Active comparator | Drug: Clopidogrel onlyClopidogrel monotherapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin and clopidogrelat the discretion of investigator | Drug | DAPT |
| Clopidogrel onlyat the discretion of investigator | Drug | Clopidogrel only |
Primary outcome
composite event of death, myocardial infarction, or stroke
Time frame: 1 year
7 secondary outcomes
Death
Time frame: 5 years
Myocardial Infarction
Time frame: 5 years
Stroke
Time frame: 5 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Percutaneous Transluminal Coronary Angioplasty
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure
RecruitingObservational study
Vascular Complications After Kidney Transplantation
Kidney Transplant Recipient, Kidney Transplant; Complications
Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Enrolling by invitationObservational study
One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
RecruitingObservational study
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin and clopidogrel and Clopidogrel only in people with Percutaneous Transluminal Coronary Angioplasty and Coronary Disease, run by Seung-Jung Park at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite event of death, myocardial infarction, or stroke (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.