Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
NCT ID: NCT06909565
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
6000 participants
INTERVENTIONAL
2025-07-23
2029-12-31
Brief Summary
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Detailed Description
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The enrollment population will be representative of typical patients in the US with atherosclerotic cardiovascular disease, either coronary artery disease (CAD) or peripheral artery disease (PAD), and the trial endpoints are designed to be scientifically relevant and clinically meaningful to patients, clinicians, and other persons involved in the care of cardiovascular patients. The trial is designed to also understand how inclisiran therapy can be implemented in real-world clinical practice settings.
The expected enrollment of the trial is approximately 6,000 participants, randomized in a 1:1 fashion to receive inclisiran or placebo, within 14 days of successful percutaneous coronary or lower extremity peripheral endovascular intervention for symptomatic atherosclerotic cardiovascular disease (ASCVD).
Inclisiran sodium or corresponding placebo will be administered by s.c. injection to participants presenting for percutaneous coronary or peripheral endovascular intervention, in addition to usual care according to their individual medical history. All participants randomized to the treatment arm will receive inclisiran in addition to usual care per their regular physician direction, and those participants randomized to placebo will receive matching placebo, as well as usual care treatment, according to their treating physician.
Study duration is determined by event accrual consistent with the event-driven design, i.e., when approximately 2380 primary composite events have occurred and at least 50% of participants have at least 36 months of follow-up. Assuming 18 months of recruitment at a uniform rate, the last patients enrolled will have about 27 months of follow-up. Therefore, study duration should be approximately 4 years.
The study is event-driven, and thus, all participants will be treated (or followed in the case of permanent discontinuation of study drug) until the End of Study visit. As such, the planned duration of treatment cannot be stipulated for an individual participant. The estimated maximum treatment period for an individual participant is approximately 45 months, and the mean treatment duration is expected to be approximately 36 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Inclisiran Sodium
Inclisiran sodium 300 mg subcutaneous injection
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
Placebo
Normal saline 1.5 ml subcutaneous injection
Normal Saline (Placebo)
Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter
Interventions
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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
Normal Saline (Placebo)
Normal saline placebo subcutaneous injection given at Day 0, Day 90; \& every 6 months thereafter
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Colorado Prevention Center
OTHER
Mount Sinai Hospital, New York
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Schuyler Jones, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Marc Bonaca, MD
Role: PRINCIPAL_INVESTIGATOR
Colorado Prevention Center
Roxana Mehran, MD
Role: STUDY_CHAIR
Mt Sinai
Manesh Patel, MD
Role: STUDY_CHAIR
Duke University
Locations
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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
The Heart Medical Group
Van Nuys, California, United States
Interventional Cardiology Medical Group
West Hills, California, 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
Tampa Cardiovascular Interventions and Research
Tampa, Florida, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States
Grace Research, LLC
Bossier City, Louisiana, United States
Louisiana Heart Center
Covington, Louisiana, United States
Cardiovascular Solutions, LLC
Shreveport, Louisiana, United States
Northern Light Eastern Maine Medical Center
Bangor, Maine, United States
UMH-Sparrow Clinical Research Institute
Lansing, Michigan, United States
MyMichigan Medical Center Midland
Midland, Michigan, United States
Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
Rochester Hills, Michigan, United States
CHI Health Nebraska Heart
Grand Island, Nebraska, United States
CHI Health Nebraska Heart
Lincoln, Nebraska, United States
Advanced Heart Care LLC
Bridgewater, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, United States
Trinity Medical WNY, PC
Buffalo, New York, United States
Mecklenburg Heart Specialists
Charlotte, North Carolina, United States
Duke Cardiology
Morrisville, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Heart House Research Foundation LLC
Springfield, Ohio, United States
Genesis HealthCare System
Zanesville, Ohio, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, United States
Capital Area Research LLC
Camp Hill, Pennsylvania, United States
Apex Research Foundation, LLC
Jackson, Tennessee, United States
PharmaTex Research
Amarillo, Texas, United States
Amarillo Heart Clinical Research Institute, Inc.
Amarillo, Texas, United States
TPMG Clinical Research
Newport News, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Sabrina Forbus
Role: primary
Cynthia Abath
Role: primary
Bobbi Phillips
Role: primary
Victor Guerro
Role: primary
Breanna Culver
Role: primary
Morgan Stoaks
Role: primary
Monica Brown
Role: primary
Monica Brown
Role: primary
Michael Fam
Role: primary
Carolyn Rembish
Role: primary
Jeff Somerstein
Role: primary
Albert Garcia
Role: primary
Teresa Jones
Role: primary
Dora Gutierrez
Role: primary
Shelley Sherk
Role: primary
Hanna Bishop
Role: primary
Laura Jenkins
Role: primary
Allis Delafield
Role: primary
Elizabeth Fulks
Role: primary
Laurie Hall
Role: primary
Sherri Dragon
Role: primary
Elisha Strahan
Role: primary
Tedd Walther
Role: primary
Lonna Blaske
Role: primary
Jamie Prior
Role: primary
Eveit Toma
Role: primary
Melissa Kelley
Role: primary
Julie Potter
Role: primary
Sivaradhika Yandamuri
Role: primary
Traci Vogt
Role: primary
Kaitlyn Downey
Role: primary
Sue Manga
Role: primary
Jalak Upadhyay
Role: primary
Emad Ghaly
Role: primary
Erin Campo
Role: primary
Barbara Rambaud
Role: primary
Kylie Hubbard
Role: primary
Carolyn Griffin
Role: primary
Rachel Burgan
Role: primary
Alison Singh
Role: primary
Pam Gibbons
Role: primary
Alexandra Sims
Role: primary
Susan Nguyen
Role: primary
Heather Freeman
Role: primary
References
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Navar AM, Shah NP, Shrader P, Thomas LE, Ahmad Z, Allred C, Chamberlain AM, Chrischilles EA, Dhalwani N, Effron MB, Hayek S, Jones LK, Kalich B, Shapiro MD, Wojcik C, Peterson ED. Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry. Am Heart J. 2025 Jan;279:107-117. doi: 10.1016/j.ahj.2024.06.012. Epub 2024 Jul 6.
Chamberlain AM, Gong Y, Shaw KM, Bian J, Song WL, Linton MF, Fonseca V, Price-Haywood E, Guhl E, King JB, Shah RU, Puro J, Shenkman E, Pawloski PA, Margolis KL, Hernandez AF, Cooper-DeHoff RM. PCSK9 Inhibitor Use in the Real World: Data From the National Patient-Centered Research Network. J Am Heart Assoc. 2019 May 7;8(9):e011246. doi: 10.1161/JAHA.118.011246.
Other Identifiers
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CKJX839D1US04R
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00116826
Identifier Type: -
Identifier Source: org_study_id