NCT06909565 · Duke University
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)
What this study is about
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 injected under the skin, 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.
View original scientific description
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
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
Primary outcome measures
Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization
Time frame: From randomization to first occurrence of MACE (up to approximately 4 years)
MACEs include CHD death, non-fatal MI, ischemic stroke, ALI, major (above the ankle) amputation of vascular etiology, clinically driven coronary and limb revascularization.
Total number of major adverse limb events (MALE) after endovascular revascularization
Time frame: From randomization to first occurrence of MALE (up to approximately 4 years)
MALEs consist of ALI, major amputation of vascular etiology, clinically driven lower extremity peripheral revascularization.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 s
Where
- Alexander City, Alabama
- Birmingham, Alabama
- Huntsville, Alabama
- Jonesboro, Arkansas
- Little Rock, Arkansas
- Beverly Hills, California
- Chula Vista, California
- Covina, California
- Newport Beach, California
- Northridge, California
- Riverside, California
- San Diego, California
And 91 more locations — see the full list below.
Collaborators
Novartis Pharmaceuticals, Colorado Prevention Center, Mount Sinai Hospital, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations