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 (28) 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
California
Pacific Oaks Medical Group
RECRUITING
Beverly Hills
Valley Clinical Trials
RECRUITING
Covina
Radin Cardiovascular Medical Group, Inc
RECRUITING
Newport Beach
Valley Clinical Trials, LLC - Flourish Research
RECRUITING
Northridge
The Heart Medical Group
RECRUITING
Van Nuys
Interventional Cardiology Medical Group
RECRUITING
West Hills
Florida
Clearwater Cardiovascular Consultants
RECRUITING
Clearwater
Arrow Clinical Trails
RECRUITING
Daytona Beach
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
RECRUITING
Largo
Inpatient Research Clinic, LLC
RECRUITING
Miami Lakes
Clearwater Cardiovascular Consultants
RECRUITING
Safety Harbor
Tampa Cardiovascular Interventions and Research
RECRUITING
Tampa
Kansas
Midwest Heart and Vascular Specialists
RECRUITING
Overland Park
Louisiana
Cardiovascular Solutions, LLC
RECRUITING
Shreveport
Maine
Northern Light Eastern Maine Medical Center
RECRUITING
Bangor
North Carolina
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
Cardiovascular Associates of the Delaware Valley
RECRUITING
Haddon Heights
Cardiovascular Associates of the Delaware Valley
RECRUITING
Sewell
Ohio
Aultman Hospital
RECRUITING
Canton
Heart House Research Foundation LLC
RECRUITING
Springfield
Oklahoma
South Oklahoma Heart Research, LLC
RECRUITING
Oklahoma City
Pennsylvania
Capital Area Research LLC
RECRUITING
Camp Hill
Texas
PharmaTex Research
RECRUITING
Amarillo
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
Sponsors
Collaborators: Mount Sinai Hospital, New York, Colorado Prevention Center, Novartis Pharmaceuticals
Leads: Duke University

This content was sourced from clinicaltrials.gov