Inclisiran for Cardiovascular and Limb Event Prevention

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

Recruiting Phase 4 Interventional Study
Percutaneous Coronary Intervention Peripheral Endovascular Intervention
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
6,000 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for

This trial is looking for adults who have recently had a procedure to open blocked arteries. Participants will receive a treatment called inclisiran, which is an injection given twice a year to help prevent serious heart and limb issues.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have had a successful heart or leg artery procedure within the last 14 days.
  • I have signed the consent form to participate in the study.

You may not be able to join if

  • I have a planned future heart or leg artery procedure.
  • I am currently using or plan to use a PCSK9 inhibitor during the study.
  • I have previously received treatment with inclisiran.
  • I am participating in another clinical study with experimental drugs or devices.
  • I have serious liver disease or other serious health conditions that may affect my participation.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
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…
Contacts

Robin Barron-Nelson, RN, MSN

321-946-2747

robin.barron-nelson@duke.edu

CONTACT

Jen Holt

+1 919 824 6334

jen.holt@duke.edu

CONTACT