RECRUITING

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-07
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06909565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent must be obtained prior to participation in the study.
  2. * Males or females ≥ 18 years of age
  3. * Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD
  4. * Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention
  1. * Planned future PCI or PVI
  2. * Current or planned use of an open-label PCSK9 inhibitor during the study
  3. * Any prior treatment with inclisiran
  4. * Active or planned participation in another clinical study involving investigational drugs or devices during the study
  5. * 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
  6. * 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
  7. * Patients taking prohibited therapies as listed in Section 6.6.3
  8. * Pregnant or breast-feeding women

Contacts and Locations

Study Contact

Robin Barron-Nelson, RN, MSN
CONTACT
321-946-2747
robin.barron-nelson@duke.edu
Jen Holt
CONTACT
+1 919 824 6334
jen.holt@duke.edu

Principal Investigator

Schuyler Jones, MD
PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute

Study Locations (Sites)

Pacific Oaks Medical Group
Beverly Hills, California, 90211
United States
Radin Cardiovascular Medical Group, Inc
Newport Beach, California, 92663
United States
Advanced Heart Care LLC
Bridgewater, New Jersey, 08807
United States

Collaborators and Investigators

Sponsor: Duke University

  • Schuyler Jones, MD, PRINCIPAL_INVESTIGATOR, Duke Clinical Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2029-12

Study Record Updates

Study Start Date2025-07
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • inclisiran
  • Coronary Artery Disease
  • hypercholesterolemia
  • Cardiovascular Disease
  • Percutaneous Endovascular Intervention
  • Percutaneous Coronary Intervention
  • PCSK9

Additional Relevant MeSH Terms

  • Percutaneous Coronary Intervention
  • Peripheral Endovascular Intervention