NCT06909565 Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
| NCT ID | NCT06909565 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Duke University |
| Condition | Percutaneous Coronary Intervention |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 6,000 participants in total. It began in 2025-07-23 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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 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 * 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
Contact & Investigator
Schuyler Jones, MD
PRINCIPAL INVESTIGATOR
Duke Clinical Research Institute
Frequently Asked Questions
Who can join the NCT06909565 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Percutaneous Coronary Intervention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06909565 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06909565 currently recruiting?
Yes, NCT06909565 is actively recruiting participants. Contact the research team at robin.barron-nelson@duke.edu for enrollment information.
Where is the NCT06909565 trial being conducted?
This trial is being conducted at Alexander City, United States, Birmingham, United States, Huntsville, United States, Avondale, United States and 11 additional locations.
Who is sponsoring the NCT06909565 clinical trial?
NCT06909565 is sponsored by Duke University. The principal investigator is Schuyler Jones, MD at Duke Clinical Research Institute. The trial plans to enroll 6,000 participants.