Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
V-INTERVENTION
Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)
2 other identifiers
interventional
6,000
1 country
102
Brief Summary
V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2025
Longer than P75 for phase_4
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2025
CompletedFirst Posted
Study publicly available on registry
April 3, 2025
CompletedStudy Start
First participant enrolled
July 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
June 10, 2026
July 1, 2025
4.2 years
March 27, 2025
June 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization
MACEs include CHD death, non-fatal MI, ischemic stroke, ALI, major (above the ankle) amputation of vascular etiology, clinically driven coronary and limb revascularization.
From randomization to first occurrence of MACE (up to approximately 4 years)
Total number of major adverse limb events (MALE) after endovascular revascularization
MALEs consist of ALI, major amputation of vascular etiology, clinically driven lower extremity peripheral revascularization.
From randomization to first occurrence of MALE (up to approximately 4 years)
Secondary Outcomes (3)
Number of participants with cardiovascular (CV) death
From randomization to CV death (up to approximately 4 years)
Number of participants with all cause death
From randomization to all cause death (up to approximately 4 years)
Number of participants with venous thromboembolic events (VTE)
From randomization to first VTE (up to approximately 4 years)
Study Arms (2)
Inclisiran Sodium
ACTIVE COMPARATORInclisiran sodium 300 mg subcutaneous injection
Placebo
PLACEBO COMPARATORNormal saline 1.5 ml subcutaneous injection
Interventions
Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter
300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; \& every 6 months thereafter
Eligibility Criteria
You may qualify if:
- Signed informed consent must be obtained prior to participation in the study.
- Males or females ≥ 18 years of age
- Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD
- Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention
You may not qualify if:
- Planned future PCI or PVI
- Current or planned use of an open-label PCSK9 inhibitor during the study
- Any prior treatment with inclisiran
- Active or planned participation in another clinical study involving investigational drugs or devices during the study
- Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results
- Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities
- Patients taking prohibited therapies as listed in Section 6.6.3
- Pregnant or breast-feeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mount Sinai Hospital, New Yorkcollaborator
- Duke Universitylead
- Novartis Pharmaceuticalscollaborator
- Colorado Prevention Centercollaborator
Study Sites (102)
Advanced Cardiovascular LLC
Alexander City, Alabama, 35010, United States
Cardiology, PC
Birmingham, Alabama, 35211, United States
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Arkansas Cardiology
Little Rock, Arkansas, 72205, United States
Pacific Oaks Medical Group
Beverly Hills, California, 90211, United States
Valley Clinical Trials
Covina, California, 91723, United States
Radin Cardiovascular Medical Group, Inc
Newport Beach, California, 92663, United States
Valley Clinical Trials, LLC - Flourish Research
Northridge, California, 91325, United States
Riverside Community Hospital
Riverside, California, 92501, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
The Heart Medical Group
Van Nuys, California, 91406, United States
FOMAT - West Coast Research Center
Ventura, California, 93030, United States
Interventional Cardiology Medical Group
West Hills, California, 91307, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Nuvance Health- Danbury Hospital
Danbury, Connecticut, 06810, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, 06305, United States
BayCare Medical Group
Clearwater, Florida, 33756, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756, United States
Pioneer Clinical Studies
Coral Gables, Florida, 33134, United States
Arrow Clinical Trails
Daytona Beach, Florida, 32117, United States
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
Largo, Florida, 33777, United States
Inpatient Research Clinic, LLC
Miami Lakes, Florida, 33014, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405, United States
Charlotte Heart & Vascular Center, PA
Port Charlotte, Florida, 33948, United States
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, 34695, United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, 33614, United States
Northeast Georgia Heart Center, PC
Gainesville, Georgia, 30501, United States
Javara, Inc.
Peachtree City, Georgia, 30269, United States
Atlanta Heart Specialists LLC
Tucker, Georgia, 30084, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, 46514, United States
Reid Physician Associates
Richmond, Indiana, 47374, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211, United States
Research Integrity, LLC
Owensboro, Kentucky, 42303, United States
Grace Research, LLC
Bossier City, Louisiana, 71111, United States
Louisiana Heart Center
Covington, Louisiana, 70433, United States
Tulane School of Medicine
New Orleans, Louisiana, 70112, United States
Cardiovascular Solutions, LLC
Shreveport, Louisiana, 71103, United States
Monroe Research LLC
West Monroe, Louisiana, 71291, United States
Northern Light Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Capitol Cardiology Associates PA
Lanham, Maryland, 20706, United States
Shady Grove Adventist Hospital
Rockville, Maryland, 20850, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, 21804, United States
Jadestone Clinical Research, LLC
Silver Spring, Maryland, 20904, United States
UMH-Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
MyMichigan Medical Center Midland
Midland, Michigan, 48670, United States
Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
Rochester Hills, Michigan, 48307, United States
Aspirus Saint Luke's Hospital
Duluth, Minnesota, 55805, United States
JAVARA Inc, - Mankato Clinic
Mankato, Minnesota, 56001, United States
Stern Cardiovascular
Southaven, Mississippi, 38671, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801, United States
CHI Health Nebraska Heart
Grand Island, Nebraska, 68803, United States
Bryan Heart
Lincoln, Nebraska, 68506, United States
CHI Health Nebraska Heart
Lincoln, Nebraska, 68526, United States
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska, 68114, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Advanced Heart Care LLC
Bridgewater, New Jersey, 08807, United States
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, 08318, United States
Advanced Heart and Vascular Institute Of Hunterdon
Flemington, New Jersey, 08822, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, 08080, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
Sisters of Charity Hospital
Buffalo, New York, 14214, United States
Trinity Medical WNY, PC
Buffalo, New York, 14214, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Hudson Valley Cardiovascular Practice PC
Poughkeepsie, New York, 12601, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
Asheville Cardiology Associates Research Department
Asheville, North Carolina, 28803, United States
Novant Health Clinical Research/Heart & Vascular Institute
Charlotte, North Carolina, 28204, United States
Mecklenburg Heart Specialists
Charlotte, North Carolina, 28207, United States
Javara Inc.
Fayetteville, North Carolina, 28304, United States
Duke Cardiology
Morrisville, North Carolina, 27560, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Heart House Research Foundation LLC
Springfield, Ohio, 45505, United States
Genesis HealthCare System
Zanesville, Ohio, 43701, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135, United States
Capital Area Research LLC
Camp Hill, Pennsylvania, 17011, United States
Wellspan Chambersburg Hospital
Chambersburg, Pennsylvania, 17201, United States
Penn Lancaster General Health Research Institute
Lancaster, Pennsylvania, 17602, United States
Cardiology Associates of West Reading
West Reading, Pennsylvania, 19611, United States
WellSpan Heart and Vascular Research
York, Pennsylvania, 17403, United States
AnMed Health Medical Center
Anderson, South Carolina, 29621, United States
Stern Cardiovascular Center
Germantown, Tennessee, 38138, United States
Apex Research Foundation, LLC
Jackson, Tennessee, 38301, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
PharmaTex Research
Amarillo, Texas, 79106, United States
Amarillo Heart Clinical Research Institute, Inc.
Amarillo, Texas, 79124, United States
Austin Heart
Austin, Texas, 78705, United States
Javara inc.
Conroe, Texas, 77384, United States
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339, United States
Heart Institute of East Texas
Lufkin, Texas, 75904, United States
Austin Heart PLLC
Round Rock, Texas, 78681, United States
Austin Heart
San Marcos, Texas, 78666, United States
Northwest Houston Heart Center
Tomball, Texas, 77375, United States
Viva Heart and Vein
Tomball, Texas, 77375, United States
TPMG Clinical Research
Newport News, Virginia, 23606, United States
Chippenham Hospital
Richmond, Virginia, 23225, United States
Winchester Cardiology and Vascular Medicine
Winchester, Virginia, 22601, United States
MultiCare Institute for Research and Innovation
Puyallup, Washington, 98372, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
Related Publications (2)
Navar AM, Shah NP, Shrader P, Thomas LE, Ahmad Z, Allred C, Chamberlain AM, Chrischilles EA, Dhalwani N, Effron MB, Hayek S, Jones LK, Kalich B, Shapiro MD, Wojcik C, Peterson ED. Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry. Am Heart J. 2025 Jan;279:107-117. doi: 10.1016/j.ahj.2024.06.012. Epub 2024 Jul 6.
PMID: 38972336BACKGROUNDChamberlain AM, Gong Y, Shaw KM, Bian J, Song WL, Linton MF, Fonseca V, Price-Haywood E, Guhl E, King JB, Shah RU, Puro J, Shenkman E, Pawloski PA, Margolis KL, Hernandez AF, Cooper-DeHoff RM. PCSK9 Inhibitor Use in the Real World: Data From the National Patient-Centered Research Network. J Am Heart Assoc. 2019 May 7;8(9):e011246. doi: 10.1161/JAHA.118.011246.
PMID: 31020929BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Schuyler Jones, MD
Duke Clinical Research Institute
- PRINCIPAL INVESTIGATOR
Marc Bonaca, MD
Colorado Prevention Center
- STUDY CHAIR
Roxana Mehran, MD
Mt Sinai
- STUDY CHAIR
Manesh Patel, MD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2025
First Posted
April 3, 2025
Study Start
July 23, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
June 10, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share