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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02316886




Registration number
NCT02316886
Ethics application status
Date submitted
1/12/2014
Date registered
15/12/2014
Date last updated
18/11/2023

Titles & IDs
Public title
Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque
Scientific 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
Secondary ID [1] 0 0
AMCCV2014-13
Universal Trial Number (UTN)
Trial acronym
PREVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Plaque, Atherosclerotic 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Coronary intervention

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

Active comparator: Optimal Medical Treatment - Optimal Medical Treatment


Treatment: Devices: Coronary intervention
bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Target vessel failure
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Death from cardiac causes
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Target-vessel myocardial infarction
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Ischemic-driven target-vessel revascularization
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Hospitalization for unstable or progressive angina
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Death from all, cardiac, or noncardiac causes
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Myocardial infarction
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Repeat revascularization
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Any hospitalization for cardiac or noncardiac causes
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Target-lesion failure
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
Major adverse cardiac event
Timepoint [10] 0 0
2 years
Secondary outcome [11] 0 0
Composite of any death, myocardial infarction, or repeat revascularization
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Rate of Scaffold or stent thrombosis
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
Rate of Stroke
Timepoint [13] 0 0
2 years
Secondary outcome [14] 0 0
Rate of Bleeding events
Timepoint [14] 0 0
2 years
Secondary outcome [15] 0 0
Rate of Nonurgent revascularization procedures
Timepoint [15] 0 0
2 years
Secondary outcome [16] 0 0
Functional class
Timepoint [16] 0 0
2 years
Secondary outcome [17] 0 0
Number of anti-anginal medications administered
Timepoint [17] 0 0
2 years

Eligibility
Key inclusion criteria
* 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:

1. MLA(minimal luminal area)<4mm2
2. Plaque burden>70%
3. Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315
4. 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2023
Sample size
Target
Accrual to date
Final
1608
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Japan
State/province [2] 0 0
Kyoto
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Songpa-gu
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Anyang
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Chuncheon
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Daegu
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Daejeon
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Gwangju
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Incheon
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Jeonju
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Songnam
Country [13] 0 0
New Zealand
State/province [13] 0 0
Christchurch
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Other
Name
Seung-Jung Park
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CardioVascular Research Foundation, Korea
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/study/NCT02316886
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Duk-woo Park, MD
Address 0 0
Asan Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02316886