Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Recruiting · NCT06909565 · Interventional (participants receive a specific treatment) · Lead sponsor: Duke University
View the official record on ClinicalTrials.gov →Interventions studied
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mLNormal Saline (Placebo)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
60 locations listed across 36 US states.
- 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
- 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
- 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
- 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
- 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
- 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
Showing 60 of 138 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →