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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: Recruiting Phase 4 study of Percutaneous Coronary Intervention and Peripheral Endovascular Intervention, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MACEs include CHD death, non-fatal MI, ischemic stroke, ALI, major (above the ankle) amputation of vascular etiology, clinically driven coronary and limb revascularization.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 6,000 participants |
| Start Date | 2025-07-23 |
| Est. Completion | 2029-12 |
| Phase | Phase 4 |
What NCT06909565 shows while recruiting
NCT06909565 is an interventional study that assigns participants to a tested intervention. Its 6,000 participants enrollment target places it among the larger protocols in the corpus, above the 4,725-participant average among 12 other Percutaneous Coronary Intervention trials with a reported enrollment target (27% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06909565's enrollment target sits among peer trials
6,000 3rd of 12 higher than 10 of 12 other Percutaneous Coronary Intervention trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Percutaneous Coronary Intervention trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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