NCT06909565RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular 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)
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 6000 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 23 Jul 2025
- Primary completion date
- Oct 2029
- Lead sponsor
- Duke University
- NCT number
- NCT06909565
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 6000
- From 23 Jul 2025 to the primary completion date, Oct 2029
- 149 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients taking prohibited therapies as listed in Section 6.6.3
Other illness
- 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
Other
- Planned future PCI or PVI
- 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
- Pregnant or breast-feeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (149)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Capital Cardiology Associates Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| Presbyterian Heart Group Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Advanced Cardiovascular, LLC Coordinator of this site? Confirm its status | Alexander City | United States | Recruiting |
| PharmaTex Research Coordinator of this site? Confirm its status | Amarillo | United States | Recruiting |
| Amarillo Heart Clinical Research Institute, Inc. Coordinator of this site? Confirm its status | Amarillo | United States | Recruiting |
| AnMed Health Medical Center Coordinator of this site? Confirm its status | Anderson | United States | Recruiting |
| Asheville Cardiology Associates Research Department Coordinator of this site? Confirm its status | Asheville | United States | Recruiting |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Austin Heart Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| IMS Cardiology Coordinator of this site? Confirm its status | Avondale | United States | Recruiting |
| Northern Light Eastern Maine Medical Center Coordinator of this site? Confirm its status | Bangor | United States | Recruiting |
| St. Luke's University Health Network Coordinator of this site? Confirm its status | Bethlehem | United States | Recruiting |
| Pacific Oaks Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| Cardiology, PC Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Grace Research LLC Coordinator of this site? Confirm its status | Bossier City | United States | Recruiting |
| Bridgeport Hospital Coordinator of this site? Confirm its status | Bridgeport | United States | Recruiting |
| Advanced Heart Care LLC Coordinator of this site? Confirm its status | Bridgewater | United States | Recruiting |
| Sisters of Charity Hospital Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Trinity Medical WNY, PC Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| Capital Area Research, LLC Coordinator of this site? Confirm its status | Camp Hill | United States | Recruiting |
| Aultman Hospital Coordinator of this site? Confirm its status | Canton | United States | Recruiting |
| Wellspan Chambersburg Hospital Coordinator of this site? Confirm its status | Chambersburg | United States | Recruiting |
| Novant Health Clinical Research/Heart & Vascular Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Mecklenburg Heart Specialists Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| University of Illinois Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cardiovascular Institute of San Diego Coordinator of this site? Confirm its status | Chula Vista | United States | Recruiting |
| Baycare Medical Group Coordinator of this site? Confirm its status | Clearwater | United States | Recruiting |
| Clearwater Cardiovascular Consultants Coordinator of this site? Confirm its status | Clearwater | United States | Recruiting |
| Medstar Southern Maryland Hospital Center Coordinator of this site? Confirm its status | Clinton | United States | Recruiting |
| University of Missouri Health Care Coordinator of this site? Confirm its status | Columbia | United States | Recruiting |
| John Muir Medical Center-Concord Campus Coordinator of this site? Confirm its status | Concord | United States | Recruiting |
| Javara inc. Coordinator of this site? Confirm its status | Conroe | United States | Withdrawn |
| Pioneer Clinical Studies Coordinator of this site? Confirm its status | Coral Gables | United States | Recruiting |
| Valley Clinical Trials Coordinator of this site? Confirm its status | Covina | United States | Withdrawn |
| Louisiana Heart Center Coordinator of this site? Confirm its status | Covington | United States | Recruiting |
| Nuvance Health-Danbury Hospital Coordinator of this site? Confirm its status | Danbury | United States | Recruiting |
| Cardiology Research Associates Coordinator of this site? Confirm its status | Daytona Beach | United States | Recruiting |
| Arrow Clinical Trails Coordinator of this site? Confirm its status | Daytona Beach | United States | Recruiting |
| Essentia Health-SMMC Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Aspirus Saint Luke's Hospital Coordinator of this site? Confirm its status | Duluth | United States | Recruiting |
| Midwest Cardiovascular Research and Education Foundation Coordinator of this site? Confirm its status | Elkhart | United States | Recruiting |
| Cardiovascular Associates of the Delaware Valley Coordinator of this site? Confirm its status | Elmer | United States | Recruiting |
| Aurora Denver Cardiology Associates - Englewood Coordinator of this site? Confirm its status | Englewood | United States | Recruiting |
| Javara Inc. Coordinator of this site? Confirm its status | Fayetteville | United States | Recruiting |
| Advanced Heart and Vascular Institute of Hunterdon Coordinator of this site? Confirm its status | Flemington | United States | Recruiting |
| Northeast Georgia Heart Center, PC Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| Stern Cardiovascular Center Coordinator of this site? Confirm its status | Germantown | United States | Recruiting |
| Thrive Clinical Research Group Coordinator of this site? Confirm its status | Glendora | United States | Recruiting |
| CHI Health Nebraska Heart Coordinator of this site? Confirm its status | Grand Island | United States | Recruiting |
| Bellin Memorial Hospital Coordinator of this site? Confirm its status | Green Bay | United States | Recruiting |
| Ballad Health System Coordinator of this site? Confirm its status | Greeneville | United States | Recruiting |
| Moses H Cone Memorial Hospital Coordinator of this site? Confirm its status | Greensboro | United States | Recruiting |
| Cardiovascular Associates of the Delaware Valley Coordinator of this site? Confirm its status | Haddon Heights | United States | Recruiting |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | High Point | United States | Recruiting |
| Texas Heart Institute Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Vital Heart and Vein Coordinator of this site? Confirm its status | Humble | United States | Recruiting |
| Heart Center Research, LLC Coordinator of this site? Confirm its status | Huntsville | United States | Recruiting |
| The Jackson Clinic, PA Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Apex Research Foundation, LLC Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| First Coast Cardiovascular Institute PA Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| UF Health Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Cardiology Associates Research Group Coordinator of this site? Confirm its status | Jonesboro | United States | Recruiting |
| Texas Cardiology Associates of Houston Coordinator of this site? Confirm its status | Kingwood | United States | Recruiting |
| Penn Lancaster General Health Research Institute Coordinator of this site? Confirm its status | Lancaster | United States | Recruiting |
| Capitol Cardiology Associates PA Coordinator of this site? Confirm its status | Lanham | United States | Recruiting |
| UMH-Sparrow Clinical Research Institute Coordinator of this site? Confirm its status | Lansing | United States | Recruiting |
| McLaren Center for Research and Innovation Coordinator of this site? Confirm its status | Lansing | United States | Recruiting |
| Clearwater Cardiovascular and Interventional Consultants- Bardmoor Coordinator of this site? Confirm its status | Largo | United States | Recruiting |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| Bryan Heart Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| CHI Health Nebraska Heart Coordinator of this site? Confirm its status | Lincoln | United States | Recruiting |
| Arkansas Heart Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Arkansas Cardiology Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Heart Institute of East Texas Coordinator of this site? Confirm its status | Lufkin | United States | Recruiting |
| JAVARA Inc, - Mankato Clinic Coordinator of this site? Confirm its status | Mankato | United States | Recruiting |
| DHR Health Institute for Research Coordinator of this site? Confirm its status | McAllen | United States | Recruiting |
| Heart Center of Lake County Coordinator of this site? Confirm its status | Merrillville | United States | Recruiting |
| Inpatient Research Clinic LLC Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| MyMichigan Medical Center Midland Coordinator of this site? Confirm its status | Midland | United States | Recruiting |
| Aurora Saint Luke's Medical Center Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Duke Cardiology Coordinator of this site? Confirm its status | Morrisville | United States | Recruiting |
| Intermountain Medical Center Coordinator of this site? Confirm its status | Murray | United States | Recruiting |
| TriStar Centennial Medical center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Tulane School of Medicine Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Radin Cardiovascular Medical Group, Inc Coordinator of this site? Confirm its status | Newport Beach | United States | Recruiting |
| TPMG Clinical Research Coordinator of this site? Confirm its status | Newport News | United States | Recruiting |
| Mount Sinai School of Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Sentara Norfolk General Hospital Coordinator of this site? Confirm its status | Norfolk | United States | Recruiting |
| Valley Clinical Trials, LLC - Flourish Research Coordinator of this site? Confirm its status | Northridge | United States | Recruiting |
| Amicis Research Coordinator of this site? Confirm its status | Northridge | United States | Recruiting |
| South Oklahoma Heart Research LLC Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Methodist Physicians Clinic Heart Consultants Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Midwest Heart and Vascular Specialists Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Research Integrity LLC Coordinator of this site? Confirm its status | Owensboro | United States | Recruiting |
| Cardiovascular Institute of Northwest Florida Coordinator of this site? Confirm its status | Panama City | United States | Recruiting |
| Gulf Coast Heart and Vascular Coordinator of this site? Confirm its status | Panama City | United States | Recruiting |
| Advocate Aurora Lutheran General Hospital Coordinator of this site? Confirm its status | Park Ridge | United States | Recruiting |
| Javara, Inc. Coordinator of this site? Confirm its status | Peachtree City | United States | Withdrawn |
| OSF Multi-Specialty Group Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| AtlantiCare Regional Medical Center Coordinator of this site? Confirm its status | Pomona | United States | Recruiting |
| Trinity Health Oakland Hospital Coordinator of this site? Confirm its status | Pontiac | United States | Recruiting |
| Charlotte Heart & Vascular Center, PA Coordinator of this site? Confirm its status | Port Charlotte | United States | Recruiting |
| Hudson Valley Cardiovascular Practice PC Coordinator of this site? Confirm its status | Poughkeepsie | United States | Recruiting |
| MultiCare Institute for Research and Innovation Coordinator of this site? Confirm its status | Puyallup | United States | Recruiting |
| Duke Vascular Surgery and Vein Center at Brier Creek Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
| Monument Health Clinical Research Coordinator of this site? Confirm its status | Rapid City | United States | Recruiting |
| Chippenham Hospital Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Reid Physician Associates Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Riverside Community Hospital Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates Coordinator of this site? Confirm its status | Rochester Hills | United States | Recruiting |
| OSF HealthCare Cardiovascular Institute Coordinator of this site? Confirm its status | Rockford | United States | Recruiting |
| Shady Grove Adventist Hospital Coordinator of this site? Confirm its status | Rockville | United States | Recruiting |
| Austin Heart PLLC Coordinator of this site? Confirm its status | Round Rock | United States | Recruiting |
| Clearwater Cardiovascular Consultants Coordinator of this site? Confirm its status | Safety Harbor | United States | Active, not recruiting |
| TidalHealth Peninsula Regional Coordinator of this site? Confirm its status | Salisbury | United States | Recruiting |
| San Diego Cardiac Center Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Kaiser Permanente - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Sutter Health Heart and Vascular Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Austin Heart Coordinator of this site? Confirm its status | San Marcos | United States | Recruiting |
| Cardiovascular Associates of the Delaware Valley Coordinator of this site? Confirm its status | Sewell | United States | Recruiting |
| Cardiovascular Solutions LLC Coordinator of this site? Confirm its status | Shreveport | United States | Recruiting |
| Jadestone Clinical Research, LLC Coordinator of this site? Confirm its status | Silver Spring | United States | Recruiting |
| Stern Cardiovascular Coordinator of this site? Confirm its status | Southaven | United States | Recruiting |
| Heart House Research Foundation LLC Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Cardiology Associates of Fairfield County Coordinator of this site? Confirm its status | Stamford | United States | Recruiting |
| Richmond University Medical Center Coordinator of this site? Confirm its status | Staten Island | United States | Recruiting |
| MultiCare Institute for Research and Innovation Coordinator of this site? Confirm its status | Tacoma | United States | Recruiting |
| Washington Vascular Specialists - ClinRe 001-136 Coordinator of this site? Confirm its status | Takoma Park | United States | Recruiting |
| Tampa Cardiovascular Interventions and Research Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Jacobi Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| ClinRe 001-001 Coordinator of this site? Confirm its status | Thornton | United States | Recruiting |
| ProMedica Toledo Hospital Coordinator of this site? Confirm its status | Toledo | United States | Recruiting |
| Viva Heart and Vein Coordinator of this site? Confirm its status | Tomball | United States | Recruiting |
| Northwest Houston Heart Center Coordinator of this site? Confirm its status | Tomball | United States | Recruiting |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
| Atlanta Heart Specialists LLC Coordinator of this site? Confirm its status | Tucker | United States | Recruiting |
| Cardiology Associates of North Mississippi Coordinator of this site? Confirm its status | Tupelo | United States | Recruiting |
| The Heart Medical Group Coordinator of this site? Confirm its status | Van Nuys | United States | Recruiting |
| FOMAT - West Coast Research Center Coordinator of this site? Confirm its status | Ventura | United States | Recruiting |
| Iowa Heart Center Coordinator of this site? Confirm its status | West Des Moines | United States | Recruiting |
| Interventional Cardiology Medical Group Coordinator of this site? Confirm its status | West Hills | United States | Recruiting |
| Monroe Research, LLC Coordinator of this site? Confirm its status | West Monroe | United States | Recruiting |
| Cardiology Associates of West Reading Coordinator of this site? Confirm its status | West Reading | United States | Recruiting |
| Kansas Nephrology Physicians, PA Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
| Winchester Cardiology and Vascular Medicine Coordinator of this site? Confirm its status | Winchester | United States | Recruiting |
| Novant Health Forsyth Medical Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
| WellSpan Heart and Vascular Research Coordinator of this site? Confirm its status | York | United States | Recruiting |
| Genesis HealthCare System Coordinator of this site? Confirm its status | Zanesville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.