Trial from ClinicalTrials.gov

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Trial ID
NCT02316886
Ethics application status
Date submitted
1/12/2014
Date registered
1/12/2014
Date last updated
21/08/2017

Titles & IDs
Public title
The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque
Scientific title
The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Stenosis With Vulnerable Plaque Characteristics
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
Other cardiovascular diseases
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
Treatment: drugs - Optimal Medical treatment

Experimental: Coronary intervention - Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment

Active Comparator: Optimal Medical Treatment - Optimal Medical Treatment


Treatment: devices: Coronary intervention
Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment

Treatment: drugs: Optimal Medical treatment


Intervention code [1] 0 0
Treatment: devices
Intervention code [2] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
cardiovascular death
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Nonfatal myocardial infarction
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Ischemia driven target lesion revascularization
Timepoint [3] 0 0
24 months
Secondary outcome [1] 0 0
Major adverse cardiac event - defined as cardiovascular death, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable angina
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Target vessel failure, defined as a composite of cardiovascular death, target vessel related myocardial infarction, or target vessel revascularization - The composite of death, MI, and any TVR at a mean of 2 years follow-up.
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Death from any causes
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
The composite of death, myocardial infarction, and any repeat revascularization - The composite of death, myocardial infarction, and any repeat revascularization at a mean of 2 years follow-up.
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Cardiac death and combinations of cardiac death with other components of MACE at each time point - Cardiac death and combinations of cardiac death with other components of MACE at each time point
Timepoint [5] 0 0
1 month
Secondary outcome [6] 0 0
Cardiac death and combinations of cardiac death with other components of MACE at each time point - Cardiac death and combinations of cardiac death with other components of MACE at each time point
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Cardiac death and combinations of cardiac death with other components of MACE at each time point - Cardiac death and combinations of cardiac death with other components of MACE at each time point
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Cardiac death and combinations of cardiac death with other components of MACE at each time point - Cardiac death and combinations of cardiac death with other components of MACE at each time point
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Non-urgent revascularization procedures
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
CCS(Canadian Cardiovascular Society) angina class
Timepoint [10] 0 0
1 month
Secondary outcome [11] 0 0
CCS(Canadian Cardiovascular Society) angina class
Timepoint [11] 0 0
6 months
Secondary outcome [12] 0 0
CCS(Canadian Cardiovascular Society) angina class
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
CCS(Canadian Cardiovascular Society) angina class
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Number of anti-anginal medication at each point in time
Timepoint [14] 0 0
1 month
Secondary outcome [15] 0 0
Number of anti-anginal medication at each point in time
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Number of anti-anginal medication at each point in time
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Number of anti-anginal medication at each point in time
Timepoint [17] 0 0
24 months
Secondary outcome [18] 0 0
Rate of non-urgent (repeat) revascularization at each point in time
Timepoint [18] 0 0
1 month
Secondary outcome [19] 0 0
Rate of non-urgent (repeat) revascularization at each point in time
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Rate of non-urgent (repeat) revascularization at each point in time
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Rate of non-urgent (repeat) revascularization at each point in time
Timepoint [21] 0 0
24 months

Eligibility
Key inclusion criteria
- Age 18 years or older

- Symptomatic or asymptomatic coronary artery disease patients

- Patients having at least one significant stenosis (diameter stenosis > 50%) with FFR
>0.80 and meeting two of the following:

1. MLA(minimal luminal area)<4mm2

2. plaque burden>70%

3. Lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy) (defined as
maxLCBI4mm>315)

4. TCFA(thin-cap fibroatheroma) defined by OCT(fibrous cap thickness<65µm and
arc>90°) or VH-IVUS=10% confluent NC with>30° abutting to the lumen in 3
consecutive slices)

- 2 target vulnerable lesions

- Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular
Scaffold or Everolimus Eluting Stent

- Willing and able to provide informed written consent

- Reference vessel diameter 2.75-4.0

- Lesion length = 40
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients in whom the preferred treatment is CABG(Coronary artery bypass grafting)

- Stented lesion

- Bypass graft lesion

- The patients who have more than or equal to 3 target lesions

- 2 target lesions in the same coronary territory

- Heavily calcified or angulated lesion

- Bifurcation lesion requiring 2 stenting technique

- Contraindication to or planned discontinuation of dual antiplatelet therapy within 1
year

- Life expectancy less than 2 years

- Planned cardiac surgery or planned major non cardiac 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
Blinded (masking 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Northern Hospital , Victoria Australia - Epping
Recruitment hospital [2] 0 0
Eastern Heart Clinic, Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 0 0
- Epping
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
China
State/province [5] 0 0
Hong Kong
Country [6] 0 0
Italy
State/province [6] 0 0
Milano
Country [7] 0 0
Japan
State/province [7] 0 0
Aichi
Country [8] 0 0
Japan
State/province [8] 0 0
Kurashiki
Country [9] 0 0
Japan
State/province [9] 0 0
Kyoto
Country [10] 0 0
Japan
State/province [10] 0 0
Wakayama
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Songpa-gu
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Anyang
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Busan
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Chuncheon
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Dae-jeon
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Daegu
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Daejeon
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Gwangju
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Incheon
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Jeonju
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Pusan
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Sungnam
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Suwon
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Ulsan
Country [26] 0 0
New Zealand
State/province [26] 0 0
Christchurch
Country [27] 0 0
Singapore
State/province [27] 0 0
Singapore
Country [28] 0 0
Taiwan
State/province [28] 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 purpose of this study is to determine whether preventive coronary intervention on
functionally insignificant coronary stenosis with vulnerable plaque characteristics plus
optimal medical therapy reduces the incidence of the composite of cardiovascular death,
target vessel myocardial infarction, or ischemia driven target lesion revascularization
compared with optimal medical therapy alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregg Stone, MD
Address 0 0
Columbia University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jung-Min Ahn, MD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
drjmahn@gmail.com
Contact person for scientific queries
Contact person responsible for updating information