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NCT06909565 · ClinicalTrials.gov registry record · 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

A Phase 4 study of Percutaneous Coronary Intervention and Peripheral Endovascular Intervention, sponsored by Duke University.

Recruiting
Registry status
Phase 4
Development phase
6,000
Enrollment target
20
Study locations

NCT06909565 is a Phase 4 study of Percutaneous Coronary Intervention and Peripheral Endovascular Intervention that is actively recruiting participants, run by Duke University. The registered enrollment target is 6,000 participants, above the 4,725-participant average among 12 other Percutaneous Coronary Intervention trials with a reported enrollment target (27% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT06909565, a Phase 4 study of Percutaneous Coronary Intervention and Peripheral Endovascular Intervention, is actively recruiting participants, sponsored by Duke University.

RECRUITING
Registry status
Phase 4
Development phase
6,000 participants
Enrollment target
20
Study locations

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

1,725 total trials

What the Registry Record Tells You About NCT06909565

The ClinicalTrials.gov registry entry for NCT06909565 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 6,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 4,725-participant average among 12 other Percutaneous Coronary Intervention trials with a reported enrollment target (27% higher). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

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.

NCT06909565 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Alabama.

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.

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).

Who is sponsoring clinical trial NCT06909565?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

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.

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

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