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Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Sponsor: Duke University
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6000
Start Date
2025-07-23
Completion Date
2029-12
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; \& every 6 months thereafter
Normal Saline (Placebo)
Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter
Locations (78)
Advanced Cardiovascular LLC
Alexander City, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Arkansas Cardiology
Little Rock, Arkansas, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Valley Clinical Trials
Covina, California, United States
Radin Cardiovascular Medical Group, Inc
Newport Beach, California, United States
Valley Clinical Trials, LLC - Flourish Research
Northridge, California, United States
Riverside Community Hospital
Riverside, California, United States
San Diego Cardiac Center
San Diego, California, United States
The Heart Medical Group
Van Nuys, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States
BayCare Medical Group
Clearwater, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Pioneer Clinical Studies
Coral Gables, Florida, United States
Arrow Clinical Trails
Daytona Beach, Florida, United States
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
Largo, Florida, United States
Inpatient Research Clinic, LLC
Miami Lakes, Florida, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
Charlotte Heart & Vascular Center, PA
Port Charlotte, Florida, United States
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, United States
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States
Northeast Georgia Heart Center, PC
Gainesville, Georgia, United States
Atlanta Heart Specialists LLC
Tucker, Georgia, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States
Reid Physician Associates
Richmond, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States
Grace Research, LLC
Bossier City, Louisiana, United States
Louisiana Heart Center
Covington, Louisiana, United States
Cardiovascular Solutions, LLC
Shreveport, Louisiana, United States
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States
Capitol Cardiology Associates PA
Lanham, Maryland, United States
Shady Grove Adventist Hospital
Rockville, Maryland, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, United States
Jadestone Clinical Research, LLC
Silver Spring, Maryland, United States
UMH-Sparrow Clinical Research Institute
Lansing, Michigan, United States
MyMichigan Medical Center Midland
Midland, Michigan, United States
Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
Rochester Hills, Michigan, United States
Aspirus Saint Luke's Hospital
Duluth, Minnesota, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
CHI Health Nebraska Heart
Grand Island, Nebraska, United States
CHI Health Nebraska Heart
Lincoln, Nebraska, United States
Advanced Heart Care LLC
Bridgewater, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, United States
Advanced Heart and Vascular Institute Of Hunterdon
Flemington, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States
Sisters of Charity Hospital
Buffalo, New York, United States
Trinity Medical WNY, PC
Buffalo, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
Mecklenburg Heart Specialists
Charlotte, North Carolina, United States
Duke Cardiology
Morrisville, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Heart House Research Foundation LLC
Springfield, Ohio, United States
Genesis HealthCare System
Zanesville, Ohio, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States
Capital Area Research LLC
Camp Hill, Pennsylvania, United States
Wellspan Chambersburg Hospital
Chambersburg, Pennsylvania, United States
Cardiology Associates of West Reading
West Reading, Pennsylvania, United States
WellSpan Heart and Vascular Research
York, Pennsylvania, United States
AnMed Health Medical Center
Anderson, South Carolina, United States
Stern Cardiovascular Center
Germantown, Tennessee, United States
Apex Research Foundation, LLC
Jackson, Tennessee, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
PharmaTex Research
Amarillo, Texas, United States
Amarillo Heart Clinical Research Institute, Inc.
Amarillo, Texas, United States
Austin Heart
Austin, Texas, United States
Javara inc.
Conroe, Texas, United States
Heart Institute of East Texas
Lufkin, Texas, United States
Austin Heart PLLC
Round Rock, Texas, United States
Northwest Houston Heart Center
Tomball, Texas, United States
Viva Heart and Vein
Tomball, Texas, United States
TPMG Clinical Research
Newport News, Virginia, United States
MultiCare Institute for Research and Innovation
Puyallup, Washington, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States