Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 4

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

NCT06909565 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
  • DRUG Normal Saline (Placebo)

Study Locations (20)

Florida

  • BayCare Medical Group — Clearwater
  • Clearwater Cardiovascular Consultants — Clearwater
  • Pioneer Clinical Studies — Coral Gables
  • Arrow Clinical Trails — Daytona Beach
  • Clearwater Cardiovascular and Interventional Consultants- Bardmoor — Largo
  • Inpatient Research Clinic, LLC — Miami Lakes
  • Cardiovascular Institute of Northwest Florida — Panama City
  • Charlotte Heart & Vascular Center, PA — Port Charlotte
  • Clearwater Cardiovascular Consultants — Safety Harbor

California

  • Pacific Oaks Medical Group — Beverly Hills
  • Valley Clinical Trials — Covina
  • Radin Cardiovascular Medical Group, Inc — Newport Beach
  • Valley Clinical Trials, LLC - Flourish Research — Northridge
  • Riverside Community Hospital — Riverside
  • The Heart Medical Group — Van Nuys
  • Interventional Cardiology Medical Group — West Hills

Alabama

  • Advanced Cardiovascular LLC — Alexander City
  • Heart Center Research, LLC — Huntsville

Arkansas

  • Arkansas Cardiology — Little Rock

Connecticut

  • Cardiology Associates of Fairfield County — Stamford

Trial Details

FieldValue
Enrollment Target 6,000 participants
Start Date 2025-07-23
Est. Completion 2029-12
Phase Phase 4

Sponsor

Duke University

1,129 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06909565

The ClinicalTrials.gov registry entry for NCT06909565 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Percutaneous Coronary Intervention appearing as the primary indexed condition, and to 2 interventions — of which Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06909565 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06909565 about?

NCT06909565 is a clinical study titled "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 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 th...

What is the current status of trial NCT06909565?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 6,000 participants. The study started on 2025-07-23. Estimated completion is 2029-12.

What conditions does trial NCT06909565 study?

This clinical trial studies the following conditions: Percutaneous Coronary Intervention, Peripheral Endovascular Intervention. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06909565?

The interventions under investigation include: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL (DRUG), Normal Saline (Placebo) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06909565?

This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06909565 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial