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)
Status: Recruiting
Location: See all (78) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Advanced Cardiovascular LLC
RECRUITING
Alexander City
Heart Center Research, LLC
RECRUITING
Huntsville
Arkansas
Arkansas Cardiology
RECRUITING
Little Rock
California
Pacific Oaks Medical Group
RECRUITING
Beverly Hills
Valley Clinical Trials
WITHDRAWN
Covina
Radin Cardiovascular Medical Group, Inc
RECRUITING
Newport Beach
Valley Clinical Trials, LLC - Flourish Research
RECRUITING
Northridge
Riverside Community Hospital
RECRUITING
Riverside
San Diego Cardiac Center
RECRUITING
San Diego
The Heart Medical Group
RECRUITING
Van Nuys
Interventional Cardiology Medical Group
RECRUITING
West Hills
Connecticut
Cardiology Associates of Fairfield County
RECRUITING
Stamford
Florida
BayCare Medical Group
RECRUITING
Clearwater
Clearwater Cardiovascular Consultants
RECRUITING
Clearwater
Pioneer Clinical Studies
RECRUITING
Coral Gables
Arrow Clinical Trails
RECRUITING
Daytona Beach
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
RECRUITING
Largo
Inpatient Research Clinic, LLC
RECRUITING
Miami Lakes
Cardiovascular Institute of Northwest Florida
RECRUITING
Panama City
Charlotte Heart & Vascular Center, PA
RECRUITING
Port Charlotte
Clearwater Cardiovascular Consultants
RECRUITING
Safety Harbor
Tampa Cardiovascular Interventions and Research
RECRUITING
Tampa
Georgia
Northeast Georgia Heart Center, PC
RECRUITING
Gainesville
Atlanta Heart Specialists LLC
RECRUITING
Tucker
Iowa
Iowa Heart Center
RECRUITING
West Des Moines
Indiana
Midwest Cardiovascular Research and Education Foundation
RECRUITING
Elkhart
Reid Physician Associates
RECRUITING
Richmond
Kansas
Midwest Heart and Vascular Specialists
RECRUITING
Overland Park
Louisiana
Grace Research, LLC
RECRUITING
Bossier City
Louisiana Heart Center
RECRUITING
Covington
Cardiovascular Solutions, LLC
RECRUITING
Shreveport
Maryland
Capitol Cardiology Associates PA
RECRUITING
Lanham
Shady Grove Adventist Hospital
RECRUITING
Rockville
TidalHealth Peninsula Regional
RECRUITING
Salisbury
Jadestone Clinical Research, LLC
RECRUITING
Silver Spring
Maine
Northern Light Eastern Maine Medical Center
RECRUITING
Bangor
Michigan
UMH-Sparrow Clinical Research Institute
RECRUITING
Lansing
MyMichigan Medical Center Midland
RECRUITING
Midland
Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
RECRUITING
Rochester Hills
Minnesota
Aspirus Saint Luke's Hospital
RECRUITING
Duluth
Mississippi
Cardiology Associates of North Mississippi
RECRUITING
Tupelo
North Carolina
Mecklenburg Heart Specialists
RECRUITING
Charlotte
Duke Cardiology
RECRUITING
Morrisville
Nebraska
CHI Health Nebraska Heart
RECRUITING
Grand Island
CHI Health Nebraska Heart
RECRUITING
Lincoln
New Jersey
Advanced Heart Care LLC
RECRUITING
Bridgewater
Cardiovascular Associates of the Delaware Valley
RECRUITING
Elmer
Advanced Heart and Vascular Institute Of Hunterdon
RECRUITING
Flemington
Cardiovascular Associates of the Delaware Valley
RECRUITING
Haddon Heights
AtlantiCare Regional Medical Center
RECRUITING
Pomona
Cardiovascular Associates of the Delaware Valley
RECRUITING
Sewell
New York
Sisters of Charity Hospital
RECRUITING
Buffalo
Trinity Medical WNY, PC
RECRUITING
Buffalo
Mount Sinai School of Medicine
RECRUITING
New York
Richmond University Medical Center
RECRUITING
Staten Island
Ohio
Aultman Hospital
RECRUITING
Canton
Heart House Research Foundation LLC
RECRUITING
Springfield
Genesis HealthCare System
RECRUITING
Zanesville
Oklahoma
South Oklahoma Heart Research, LLC
RECRUITING
Oklahoma City
Pennsylvania
Capital Area Research LLC
RECRUITING
Camp Hill
Wellspan Chambersburg Hospital
RECRUITING
Chambersburg
Cardiology Associates of West Reading
RECRUITING
West Reading
WellSpan Heart and Vascular Research
RECRUITING
York
South Carolina
AnMed Health Medical Center
RECRUITING
Anderson
Tennessee
Stern Cardiovascular Center
RECRUITING
Germantown
Apex Research Foundation, LLC
RECRUITING
Jackson
TriStar Centennial Medical Center
RECRUITING
Nashville
Texas
Amarillo Heart Clinical Research Institute, Inc.
RECRUITING
Amarillo
PharmaTex Research
RECRUITING
Amarillo
Austin Heart
RECRUITING
Austin
Javara inc.
RECRUITING
Conroe
Heart Institute of East Texas
RECRUITING
Lufkin
Austin Heart PLLC
RECRUITING
Round Rock
Northwest Houston Heart Center
RECRUITING
Tomball
Viva Heart and Vein
RECRUITING
Tomball
Virginia
TPMG Clinical Research
RECRUITING
Newport News
Washington
MultiCare Institute for Research and Innovation
RECRUITING
Puyallup
MultiCare Institute for Research and Innovation
RECRUITING
Tacoma
Contact Information
Primary
Robin Barron-Nelson, RN, MSN
robin.barron-nelson@duke.edu
321-946-2747
Backup
Jen Holt
jen.holt@duke.edu
+1 919 824 6334
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2029-12
Participants
Target number of participants: 6000
Treatments
Active_comparator: Inclisiran Sodium
Inclisiran sodium 300 mg subcutaneous injection
Placebo_comparator: Placebo
Normal saline 1.5 ml subcutaneous injection
Related Therapeutic Areas
Sponsors
Collaborators: Mount Sinai Hospital, New York, Colorado Prevention Center, Novartis Pharmaceuticals
Leads: Duke University