Inclisiran to prevent heart and limb events after coronary or peripheral artery procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

V-INTERVENTION (CKJX839D1US04R) is a pragmatic, randomized, double-blind, placebo-controlled, multicenter, event-driven Phase 4 trial enrolling about 6,000 adults after successful elective or urgent PCI or lower extremity PVI. Participants are randomized 1:1 to receive 300 mg inclisiran subcutaneously on Day 1 (or within 14 days of the procedure), at Month 3, and every six months thereafter, or matching placebo, with stratification by coronary versus peripheral procedure. The trial collects major adverse cardiovascular and limb events in a real-world clinical setting to determine clinical benefit beyond LDL-C lowering. The design is intended to reflect typical US practice and to inform practical implementation of inclisiran therapy.

Why it matters

Who can join: the full rules

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's running

• Advanced Cardiovascular LLC
  Alexander City, Alabama, United States Recruiting
• Cardiology, PC
  Birmingham, Alabama, United States Recruiting
• Heart Center Research, LLC
  Huntsville, Alabama, United States Recruiting
• IMS Cardiology
  Avondale, Arizona, United States Recruiting
• Cardiology Associates Research Group
  Jonesboro, Arkansas, United States Recruiting
• Arkansas Cardiology
  Little Rock, Arkansas, United States Recruiting

+99 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Schuyler Jones, MD — Duke Clinical Research Institute
• Study coordinator: Robin Barron-Nelson, RN, MSN
• Email: robin.barron-nelson@duke.edu
• Phone: 321-946-2747

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.