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

NCT06909565 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2026-05-12

No results posted yet for this 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.

Conditions

  • Percutaneous Coronary Intervention
  • Peripheral Endovascular Intervention

Interventions

DRUG

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; \& every 6 months thereafter

DRUG

Normal Saline (Placebo)

Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter

Sponsors & Collaborators

Principal Investigators

  • Schuyler Jones, MD · Duke Clinical Research Institute

  • Marc Bonaca, MD · Colorado Prevention Center

  • Roxana Mehran, MD · Mt Sinai

  • Manesh Patel, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-23
Primary Completion
2029-10-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06909565 on ClinicalTrials.gov