Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 4INTERVENTIONAL

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

Evaluation of 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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 suitable for study participation including safety considerations and the ability to adhere to protocol activities - Patients taking prohibited therapies as listed in Section 6.6.3 - Pregnant or breast-feeding women Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 suitable for study participation including safety considerations and the ability to adhere to protocol activities * Patients taking prohibited therapies as listed in Section 6.6.3 * Pregnant or breast-feeding women

Treatments Being Tested

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

Locations (20)

Advanced Cardiovascular LLC
Alexander City, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Arkansas Cardiology
Little Rock, Arkansas, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Valley Clinical Trials
Covina, California, United States
Radin Cardiovascular Medical Group, Inc
Newport Beach, California, United States
Valley Clinical Trials, LLC - Flourish Research
Northridge, California, United States
Riverside Community Hospital
Riverside, California, United States
The Heart Medical Group
Van Nuys, California, United States
Interventional Cardiology Medical Group
West Hills, California, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States
BayCare Medical Group
Clearwater, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Pioneer Clinical Studies
Coral Gables, Florida, United States
Arrow Clinical Trails
Daytona Beach, Florida, United States
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
Largo, Florida, United States
Inpatient Research Clinic, LLC
Miami Lakes, Florida, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
Charlotte Heart & Vascular Center, PA
Port Charlotte, Florida, United States
Clearwater Cardiovascular Consultants
Safety Harbor, Florida, United States