Twice-Yearly shot aims to cut heart attacks and amputations

NCT ID NCT06909565

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 16, 2026 · Updated 19 times

Summary

This study tests whether inclisiran, a twice-yearly injection that lowers cholesterol, can prevent major heart and limb events in 6,000 people who recently had artery-opening procedures. Participants receive either inclisiran or a placebo shot at the start, at 90 days, and every 6 months. The goal is to see if it reduces heart-related deaths, heart attacks, strokes, and serious limb problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Inclisiran (a twice-yearly injection to lower cholesterol)
What this could lead to: If it works, this could provide a convenient, long-acting option to reduce heart attacks, strokes, and limb complications in high-risk patients after artery procedures.
What could go wrong: This is a large phase 4 trial, but inclisiran is already approved for cholesterol lowering; the main uncertainty is whether it will significantly reduce these specific events beyond standard care. Risks include injection site reactions and possible muscle pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 6,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder coronary artery disorder Hypercholesterolemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Percutaneous coronary intervention Peripheral endovascular intervention

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

134 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Advanced Cardiovascular LLC
RECRUITING

Alexander City, Alabama, 35010, United States
Advanced Heart Care LLC
RECRUITING

Bridgewater, New Jersey, 08807, United States
Advanced Heart and Vascular Institute Of Hunterdon
RECRUITING

Flemington, New Jersey, 08822, United States
Advocate Aurora Lutheran General Hospital
RECRUITING

Park Ridge, Illinois, 60068, United States
Amarillo Heart Clinical Research Institute, Inc.
RECRUITING

Amarillo, Texas, 79124, United States
AnMed Health Medical Center
RECRUITING

Anderson, South Carolina, 29621, United States
Apex Research Foundation, LLC
RECRUITING

Jackson, Tennessee, 38301, United States
Arkansas Cardiology
RECRUITING

Little Rock, Arkansas, 72205, United States
Arkansas Heart Hospital
RECRUITING

Little Rock, Arkansas, 72211, United States
Arrow Clinical Trails
RECRUITING

Daytona Beach, Florida, 32117, United States
Asheville Cardiology Associates Research Department
RECRUITING

Asheville, North Carolina, 28803, United States
Aspirus Saint Luke's Hospital
RECRUITING

Duluth, Minnesota, 55805, United States
Atlanta Heart Specialists LLC
RECRUITING

Tucker, Georgia, 30084, United States
AtlantiCare Regional Medical Center
RECRUITING

Pomona, New Jersey, 08240, United States
Aultman Hospital
RECRUITING

Canton, Ohio, 44710, United States
Aurora Denver Cardiology Associates - Englewood
RECRUITING

Englewood, Colorado, 80113, United States
Austin Heart
RECRUITING

Austin, Texas, 78705, United States
Austin Heart
RECRUITING

San Marcos, Texas, 78666, United States
Austin Heart PLLC
RECRUITING

Round Rock, Texas, 78681, United States
Ballad Health System
RECRUITING

Greeneville, Tennessee, 37745, United States
BayCare Medical Group
RECRUITING

Clearwater, Florida, 33756, United States
Bellin Memorial Hospital
RECRUITING

Green Bay, Wisconsin, 54301, United States
Bridgeport Hospital
RECRUITING

Bridgeport, Connecticut, 06610, United States
Bryan Heart
RECRUITING

Lincoln, Nebraska, 68506, United States
CHI Health Nebraska Heart
RECRUITING

Grand Island, Nebraska, 68803, United States
CHI Health Nebraska Heart
RECRUITING

Lincoln, Nebraska, 68526, United States
Capital Area Research LLC
RECRUITING

Camp Hill, Pennsylvania, 17011, United States
Capital Cardiology Associates
RECRUITING

Albany, New York, 12211, United States
Capitol Cardiology Associates PA
RECRUITING

Lanham, Maryland, 20706, United States
Cardiology Associates Research Group
RECRUITING

Jonesboro, Arkansas, 72401, United States
Cardiology Associates of Fairfield County
RECRUITING

Stamford, Connecticut, 06305, United States
Cardiology Associates of North Mississippi
RECRUITING

Tupelo, Mississippi, 38801, United States
Cardiology Associates of West Reading
RECRUITING

West Reading, Pennsylvania, 19611, United States
Cardiology, PC
RECRUITING

Birmingham, Alabama, 35211, United States
Cardiovascular Associates of the Delaware Valley
RECRUITING

Elmer, New Jersey, 08318, United States
Cardiovascular Associates of the Delaware Valley
RECRUITING

Haddon Heights, New Jersey, 08035, United States
Cardiovascular Associates of the Delaware Valley
RECRUITING

Sewell, New Jersey, 08080, United States
Cardiovascular Institute of Northwest Florida
RECRUITING

Panama City, Florida, 32405, United States
Cardiovascular Institute of San Diego
RECRUITING

Chula Vista, California, 91911, United States
Cardiovascular Solutions, LLC
RECRUITING

Shreveport, Louisiana, 71103, United States
Charlotte Heart & Vascular Center, PA
RECRUITING

Port Charlotte, Florida, 33948, United States
Chippenham Hospital
RECRUITING

Richmond, Virginia, 23225, United States
Clearwater Cardiovascular Consultants
RECRUITING

Clearwater, Florida, 33756, United States
Clearwater Cardiovascular Consultants
ACTIVE_NOT_RECRUITING

Safety Harbor, Florida, 34695, United States
Clearwater Cardiovascular and Interventional Consultants- Bardmoor
RECRUITING

Largo, Florida, 33777, United States
ClinRe 001-001
RECRUITING

Thornton, Colorado, 80023, United States
DHR Health Institute for Research
RECRUITING

McAllen, Texas, 78504, United States
Dartmouth-Hitchcock Medical Center
RECRUITING

Lebanon, New Hampshire, 03756, United States
Duke Cardiology
RECRUITING

Morrisville, North Carolina, 27560, United States
Duke Vascular Surgery and Vein Center at Brier Creek
RECRUITING

Raleigh, North Carolina, 27617, United States
Essentia Health-SMMC
RECRUITING

Duluth, Minnesota, 55805, United States
FOMAT - West Coast Research Center
RECRUITING

Ventura, California, 93030, United States
First Coast Cardiovascular Institute, PA
RECRUITING

Jacksonville, Florida, 32256, United States
Genesis HealthCare System
RECRUITING

Zanesville, Ohio, 43701, United States
Grace Research, LLC
RECRUITING

Bossier City, Louisiana, 71111, United States
Gulf Coast Heart and Vascular
RECRUITING

Panama City, Florida, 32405, United States
Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
RECRUITING

Rochester Hills, Michigan, 48307, United States
Heart Center Research, LLC
RECRUITING

Huntsville, Alabama, 35801, United States
Heart Center of Lake County
RECRUITING

Merrillville, Indiana, 46410, United States

Contact Email: •••••@•••••
Heart House Research Foundation LLC
RECRUITING

Springfield, Ohio, 45505, United States
Heart Institute of East Texas
RECRUITING

Lufkin, Texas, 75904, United States
Hudson Valley Cardiovascular Practice PC
RECRUITING

Poughkeepsie, New York, 12601, United States
IMS Cardiology
RECRUITING

Avondale, Arizona, 85392, United States
Inpatient Research Clinic, LLC
RECRUITING

Miami Lakes, Florida, 33014, United States
Interventional Cardiology Medical Group
RECRUITING

West Hills, California, 91307, United States
Iowa Heart Center
RECRUITING

West Des Moines, Iowa, 50266, United States
JAVARA Inc, - Mankato Clinic
RECRUITING

Mankato, Minnesota, 56001, United States
Jacobi Medical Center
RECRUITING

The Bronx, New York, 10461, United States
Jadestone Clinical Research, LLC
RECRUITING

Silver Spring, Maryland, 20904, United States
Javara Inc.
RECRUITING

Fayetteville, North Carolina, 28304, United States
Javara inc.
WITHDRAWN

Conroe, Texas, 77384, United States
Javara, Inc.
WITHDRAWN

Peachtree City, Georgia, 30269, United States
John Muir Medical Center - Concord Campus
RECRUITING

Concord, California, 94520, United States
Kaiser Permanente - San Diego
RECRUITING

San Diego, California, 92123, United States
Louisiana Heart Center
RECRUITING

Covington, Louisiana, 70433, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING

Torrance, California, 90502, United States
Mecklenburg Heart Specialists
RECRUITING

Charlotte, North Carolina, 28207, United States
MedStar Southern Maryland Hospital Center
RECRUITING

Clinton, Maryland, 20735, United States
Methodist Physicians Clinic Heart Consultants
RECRUITING

Omaha, Nebraska, 68114, United States
Midwest Cardiovascular Research and Education Foundation
RECRUITING

Elkhart, Indiana, 46514, United States
Midwest Heart and Vascular Specialists
RECRUITING

Overland Park, Kansas, 66211, United States
Monroe Research LLC
RECRUITING

West Monroe, Louisiana, 71291, United States
Monument Health Clinical Research
RECRUITING

Rapid City, South Dakota, 57701, United States
Moses H Cone Memorial Hospital
RECRUITING

Greensboro, North Carolina, 27401, United States
Mount Sinai School of Medicine
RECRUITING

New York, New York, 10029, United States
MultiCare Institute for Research and Innovation
RECRUITING

Puyallup, Washington, 98372, United States
MultiCare Institute for Research and Innovation
RECRUITING

Tacoma, Washington, 98405, United States
MyMichigan Medical Center Midland
RECRUITING

Midland, Michigan, 48670, United States
Northeast Georgia Heart Center, PC
RECRUITING

Gainesville, Georgia, 30501, United States
Northern Light Eastern Maine Medical Center
RECRUITING

Bangor, Maine, 04401, United States
Northwest Houston Heart Center
RECRUITING

Tomball, Texas, 77375, United States
Novant Health Clinical Research/Heart & Vascular Institute
RECRUITING

Charlotte, North Carolina, 28204, United States
Novant Health Forsyth Medical Center
RECRUITING

Winston-Salem, North Carolina, 27103, United States
Nuvance Health- Danbury Hospital
RECRUITING

Danbury, Connecticut, 06810, United States
Pacific Oaks Medical Group
RECRUITING

Beverly Hills, California, 90211, United States
Penn Lancaster General Health Research Institute
RECRUITING

Lancaster, Pennsylvania, 17602, United States
PharmaTex Research
RECRUITING

Amarillo, Texas, 79106, United States
Pioneer Clinical Studies
RECRUITING

Coral Gables, Florida, 33134, United States
Presbyterian Heart Group
RECRUITING

Albuquerque, New Mexico, 87106, United States
ProMedica Toledo Hospital
RECRUITING

Toledo, Ohio, 43606, United States
Radin Cardiovascular Medical Group, Inc
RECRUITING

Newport Beach, California, 92663, United States
Reid Physician Associates
RECRUITING

Richmond, Indiana, 47374, United States
Research Integrity, LLC
RECRUITING

Owensboro, Kentucky, 42303, United States
Richmond University Medical Center
RECRUITING

Staten Island, New York, 10310, United States
Riverside Community Hospital
RECRUITING

Riverside, California, 92501, United States
San Diego Cardiac Center
RECRUITING

San Diego, California, 92123, United States
Sentara Norfolk General Hospital
RECRUITING

Norfolk, Virginia, 23507, United States
Shady Grove Adventist Hospital
RECRUITING

Rockville, Maryland, 20850, United States
Sisters of Charity Hospital
RECRUITING

Buffalo, New York, 14214, United States
South Oklahoma Heart Research, LLC
RECRUITING

Oklahoma City, Oklahoma, 73135, United States
St. Luke's University Health Network
RECRUITING

Bethlehem, Pennsylvania, 18015, United States
Stern Cardiovascular
RECRUITING

Southaven, Mississippi, 38671, United States
Stern Cardiovascular Center
RECRUITING

Germantown, Tennessee, 38138, United States
TPMG Clinical Research
RECRUITING

Newport News, Virginia, 23606, United States
Tampa Cardiovascular Interventions and Research
RECRUITING

Tampa, Florida, 33614, United States
Texas Cardiology Associates of Houston
RECRUITING

Kingwood, Texas, 77339, United States
The Heart Medical Group
RECRUITING

Van Nuys, California, 91406, United States
The Jackson Clinic, PA
RECRUITING

Jackson, Tennessee, 38305, United States
Thrive Clinical Research Group
RECRUITING

Glendora, California, 91740, United States
TidalHealth Peninsula Regional
RECRUITING

Salisbury, Maryland, 21804, United States
TriStar Centennial Medical Center
RECRUITING

Nashville, Tennessee, 37203, United States
Trinity Medical WNY, PC
RECRUITING

Buffalo, New York, 14214, United States
Tulane School of Medicine
RECRUITING

New Orleans, Louisiana, 70112, United States
UF Health Jacksonville
RECRUITING

Jacksonville, Florida, 32209, United States
UMH-Sparrow Clinical Research Institute
RECRUITING

Lansing, Michigan, 48912, United States
University of Colorado Anschutz Medical Campus
RECRUITING

Aurora, Colorado, 80045, United States
University of Illinois Chicago
RECRUITING

Chicago, Illinois, 60612, United States
University of Missouri Health Care
RECRUITING

Columbia, Missouri, 65212, United States
University of Rochester Medical Center
RECRUITING

Rochester, New York, 14642, United States
Valley Clinical Trials
WITHDRAWN

Covina, California, 91723, United States
Valley Clinical Trials, LLC - Flourish Research
RECRUITING

Northridge, California, 91325, United States
Vital Heart and Vein
RECRUITING

Humble, Texas, 77338, United States
Viva Heart and Vein
RECRUITING

Tomball, Texas, 77375, United States
Wake Forest University Health Sciences
RECRUITING

High Point, North Carolina, 27262, United States
Washington Vascular Specialists - ClinRe 001-136
RECRUITING

Takoma Park, Maryland, 20912, United States
WellSpan Heart and Vascular Research
RECRUITING

York, Pennsylvania, 17403, United States
Wellspan Chambersburg Hospital
RECRUITING

Chambersburg, Pennsylvania, 17201, United States
Winchester Cardiology and Vascular Medicine
RECRUITING

Winchester, Virginia, 22601, United States

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