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Coronary Artery DiseasePhase 4PREVENTNCT02316886

Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

A Phase 4 study testing Coronary intervention and Optimal Medical treatment in people with Coronary Artery Disease and Plaque, Atherosclerotic, run by Seung-Jung Park at 18 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary intervention and Optimal Medical treatment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,608 participants
Where
18 sitesin 5 countries
Study dates
5 Oct 2015to 19 Oct 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged ≥18 years
  • Patients with suspected or known Coronary artery disease who are undergoing invasive cardiac catheterization
  • Patients with at least one significant stenosis (diameter stenosis >50%) with Fractional Flow Reserve (FFR) >0.80 and meeting two of the following criteria:
  • MLA(minimal luminal area)<4mm2
  • Plaque burden>70%
  • Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315
Show all 11Show fewer
  • TCFA(thin-cap fibroatheroma) defined as fibrous cap thickness <65 μm and arc >90° on optical coherence tomography (OCT) or ≥10% confluent necrotic core with >30° abutting the lumen in three consecutive slices on Virtual-histology intravascular ultrasound (VH-IVUS)
  • Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
  • Reference vessel diameter 2.75-4.0
  • Lesion length ≤ 40mm
  • Willing and able to provide informed written consent

Who cannot join

  • Patients for whom the preferred treatment is CABG(Coronary artery bypass grafting)
  • Patients with stented lesions
  • Patients with bypass graft lesions
  • Patients with three or more target lesions
  • Patients with two target lesions in the same coronary territory
  • Patients with heavily calcified or angulated lesions
Show all 11Show fewer
  • Patients with bifurcation lesions requiring 2 stenting technique
  • Patients with contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year
  • Patients with life expectancy <2 years
  • Patients with planned cardiac or major noncardiac surgery
  • Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Trial locations and contacts

18 sites in 5 countries.

18 sites in 5 countries

South Korea14 sites

  • Hallym University Sacred Heart Hospital

    Anyang

  • Gangwon National Univ. Hospital

    Chuncheon

  • Keimyung University Dongsan Medical Center

    Daegu

  • Chungnam National University Hospital

    Daejeon

  • The Catholic University of Korea, Daejeon ST. Mary's Hospital

    Daejeon

  • Chonnam National University Hospital

    Gwangju

  • Gachon University Gil Hospital

    Incheon

  • ChonBuk National University Hospital

    Jeonju

  • Asan Medical Center

    Seoul, Songpa-gu, 138-736

  • Samsung Medical Center

    Seoul

  • Seoul National University hospital

    Seoul

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul

  • Bundang Cha Medical Center

    Sŏngnam

  • Seoul National University Bundang hospital

    Sŏngnam

Other trials in South Korea

United States1 site

  • Columbia University Medical Center

    New York, New York

Other trials in United States

Japan1 site

  • Kyoto University Hospital

    Kyoto

Other trials in Japan

New Zealand1 site

  • Christchurch Hospital and Canterbury DHB, University of Otago

    Christchurch

Other trials in New Zealand

Taiwan1 site

  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial

The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.

Read the detailed description

Sub-analysis for each imaging test will be performed as below;

  • NIRS(Near-infrared spectroscopy)
  • OCT(Optical coherence tomography)
  • VH-IVUS(IVUS-derived virtual histology)
  • IVUS(Intravascular ultrasonography)

Extended follow-up:

Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.

Being tested
Coronary intervention, Optimal Medical treatment
Keywords
coronary intervention, Vulnerable Plaque, Insignificant Stenosis, Bioresorbable Vascular Scaffold, Everolimus Eluting stent
Medical subject headings
Coronary Artery Disease, Plaque, Atherosclerotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary interventionDevice

    bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment

  • Optimal Medical treatmentDrug

Study groups in NCT02316886
Study groupRoleWhat they receive
Coronary interventionExperimentalbioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment
Receives: Device: Coronary intervention
Optimal Medical TreatmentActive comparatorOptimal Medical Treatment
Receives: Drug: Optimal Medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target vessel failure

    target-vessel failure, which was defined a composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina

    Measured: 2 years

Secondary outcomes (17)

  1. Death from cardiac causes

    Measured: 2 years

  2. Target-vessel myocardial infarction

    Measured: 2 years

  3. Ischemic-driven target-vessel revascularization

    Measured: 2 years

  4. Hospitalization for unstable or progressive angina

    Measured: 2 years

  5. Death from all, cardiac, or noncardiac causes

    Measured: 2 years

  6. Myocardial infarction

    Periprocedural or spontaneous, target-vessel or non-target-vessel related

    Measured: 2 years

  7. Repeat revascularization

    Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven)

    Measured: 2 years

  8. Any hospitalization for cardiac or noncardiac causes

    Measured: 2 years

  9. Target-lesion failure

    cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

    Measured: 2 years

  10. Major adverse cardiac event

    defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina

    Measured: 2 years

  11. Composite of any death, myocardial infarction, or repeat revascularization

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

    Measured: 2 years

  12. Rate of Scaffold or stent thrombosis

    Measured: 2 years

  13. Rate of Stroke

    Measured: 2 years

  14. Rate of Bleeding events

    life-threatening or disabling, major or minor

    Measured: 2 years

  15. Rate of Nonurgent revascularization procedures

    Measured: 2 years

  16. Functional class

    It is assessed by the Canadian Cardiovascular Society (CCS) Classification at each point in time.

    The Canadian Cardiovascular Society (CCS) classification has four categories; the minimum and maximum values are 1 and 4 respectively. A higher score means a worse outcome.

    Measured: 2 years

  17. Number of anti-anginal medications administered

    Number of anti-anginal medication at each point in time

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2014 (estimated)
  2. Study start5 Oct 2015
  3. Primary completion19 Oct 2023
  4. Study completion19 Oct 2023

Resources

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
1,608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02316886
Sponsor's protocol ID
AMCCV2014-13
Acronym
PREVENT
Status last verified
Nov 2023
First submitted
1 Dec 2014
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Wee SB, Ahn JM, Kang DY, Kim JH, Lee JB, Park HS, An SY, Seo KW, Lee SH, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao HL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang KY, Smyth D, Mintz GS, Stone GW, Park DW, Park SJ; PREVENT Investigators. Lipid Burden and Efficacy of Preventive PCI of Vulnerable Atherosclerotic Coronary Plaques: Post Hoc Analysis From the PREVENT Trial. Circulation. 2026 Oct 6. doi: 10.1161/CIRCULATIONAHA.126.080384. Online ahead of print.

    PubMed 42836296

  • Park SJ, Ahn JM, Kang DY, Yun SC, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao HL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang KY, Chae JK, Smyth D, Mintz GS, Stone GW, Park DW; PREVENT Investigators. Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial. Lancet. 2024 May 4;403(10438):1753-1765. doi: 10.1016/S0140-6736(24)00413-6. Epub 2024 Apr 8.

    PubMed 38604213

  • Ahn JM, Kang DY, Lee PH, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao PHL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang K, Chae JK, Smyth D, Stone GW, Park DW, Park SJ; PREVENT Investigators. Preventive PCI or medical therapy alone for vulnerable atherosclerotic coronary plaque: Rationale and design of the randomized, controlled PREVENT trial. Am Heart J. 2023 Oct;264:83-96. doi: 10.1016/j.ahj.2023.05.017. Epub 2023 Jun 2.

    PubMed 37271356

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coronary intervention and Optimal Medical treatment in people with Coronary Artery Disease and Plaque, Atherosclerotic, run by Seung-Jung Park at 18 sites in 5 countries.

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 11 inclusion and 11 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in South Korea, United States, Japan, New Zealand, Taiwan. 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?

Target vessel failure (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02316886, which also lists 3 linked publications.

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 18 Nov 2023.

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