Status:
RECRUITING
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Lead Sponsor:
Duke University
Collaborating Sponsors:
Novartis Pharmaceuticals
Colorado Prevention Center
Conditions:
Percutaneous Coronary Intervention
Peripheral Endovascular Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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. In...
Detailed Description
CKJX839D1US04R is a pragmatic, randomized, double-blind, parallel group, placebo-controlled, multicenter, event-driven study evaluating inclisiran sodium 300 mg subcutaneous administered on Day 1, Mon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT06909565
Start Date
July 23 2025
End Date
December 1 2029
Last Update
December 24 2025
Active Locations (44)
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1
Advanced Cardiovascular LLC
Alexander City, Alabama, United States, 35010
2
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
3
Arkansas Cardiology
Little Rock, Arkansas, United States, 72205
4
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211