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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
2026-10-29
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 (149)
Advanced Cardiovascular LLC
Alexander City, Alabama, United States
Cardiology, PC
Birmingham, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
IMS Cardiology
Avondale, Arizona, United States
Cardiology Associates Research Group
Jonesboro, Arkansas, United States
Arkansas Cardiology
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Cardiovascular Institute of San Diego
Chula Vista, California, United States
John Muir Medical Center - Concord Campus
Concord, California, United States
Valley Clinical Trials
Covina, California, United States
Thrive Clinical Research Group
Glendora, California, United States
Radin Cardiovascular Medical Group, Inc
Newport Beach, California, United States
Amicis Research
Northridge, California, United States
Valley Clinical Trials, LLC - Flourish Research
Northridge, California, United States
Riverside Community Hospital
Riverside, California, United States
Kaiser Permanente - San Diego
San Diego, California, United States
San Diego Cardiac Center
San Diego, California, United States
Sutter Health Heart and Vascular
San Francisco, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
The Heart Medical Group
Van Nuys, California, United States
FOMAT - West Coast Research Center
Ventura, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Aurora Denver Cardiology Associates - Englewood
Englewood, Colorado, United States
ClinRe 001-001
Thornton, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Nuvance Health- Danbury Hospital
Danbury, Connecticut, 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
Cardiology Research Associates
Daytona Beach, Florida, United States
UF Health Jacksonville
Jacksonville, Florida, United States
First Coast Cardiovascular Institute, PA
Jacksonville, 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
Gulf Coast Heart and Vascular
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
Javara, Inc.
Peachtree City, Georgia, United States
Atlanta Heart Specialists LLC
Tucker, Georgia, United States
University of Illinois Chicago
Chicago, Illinois, United States
Advocate Aurora Lutheran General Hospital
Park Ridge, Illinois, United States
OSF Multi-Specialty Group
Peoria, Illinois, United States
OSF HealthCare Cardiovascular Institute
Rockford, Illinois, United States
Midwest Cardiovascular Research and Education Foundation
Elkhart, Indiana, United States
Heart Center of Lake County
Merrillville, 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
Kansas Nephrology Physicians, PA
Wichita, Kansas, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
Grace Research, LLC
Bossier City, Louisiana, United States
Louisiana Heart Center
Covington, Louisiana, United States
Tulane School of Medicine
New Orleans, Louisiana, United States
Cardiovascular Solutions, LLC
Shreveport, Louisiana, United States
Monroe Research LLC
West Monroe, Louisiana, United States
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States
MedStar Southern Maryland Hospital Center
Clinton, Maryland, 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
Washington Vascular Specialists - ClinRe 001-136
Takoma Park, Maryland, United States
McLaren Center for Research and Innovation
Lansing, Michigan, United States
UMH-Sparrow Clinical Research Institute
Lansing, Michigan, United States
MyMichigan Medical Center Midland
Midland, Michigan, United States
Trinity Health Oakland Hospital
Pontiac, 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
Essentia Health-SMMC
Duluth, Minnesota, United States
JAVARA Inc, - Mankato Clinic
Mankato, Minnesota, United States
Stern Cardiovascular
Southaven, Mississippi, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
University of Missouri Health Care
Columbia, Missouri, United States
CHI Health Nebraska Heart
Grand Island, Nebraska, United States
Bryan Heart
Lincoln, Nebraska, United States
CHI Health Nebraska Heart
Lincoln, Nebraska, United States
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 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
Presbyterian Heart Group
Albuquerque, New Mexico, United States
Capital Cardiology Associates
Albany, New York, 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
Hudson Valley Cardiovascular Practice PC
Poughkeepsie, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
Jacobi Medical Center
The Bronx, New York, United States