Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

NCT ID: NCT04873934

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-24
• Study Completion Date: 2024-08-07

Brief Summary

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.

Detailed Description

This was a randomized, parallel-group, open-label, multicenter, 1-year (30-day Screening Period and 330-day Treatment Period) study comparing an LDL-C management strategy including inclisiran + usual care to usual care alone. Approximately 384 participants were planned to be randomized 1:1 to aggressive LDL-C management with inclisiran + usual care (intervention arm) (3 inclisiran doses) or usual care (control arm). Usual care could have included addition of ezetimibe, bempedoic acid, PCSK9-inhibiting monoclonal antibodies, and/or commercially available inclisiran

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inclisiran with Usual Care

Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)

Group Type: EXPERIMENTAL

Inclisiran

Intervention Type: DRUG

Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)

Usual Care

Usual Care Alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Inclisiran

Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)

Intervention Type: DRUG

Other Intervention Names

KJX839

Eligibility Criteria

Inclusion Criteria

• Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
• Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
• Fasting triglycerides <4.52 mmol/L (<400 mg/dL) at screening
• Calculated glomerular filtration rate >20 mL/min by estimated glomerular filtration rate (eGFR)
• Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose

Exclusion Criteria

• New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.
• Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
• Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
• Treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer.
• Planned use of other investigational products or devices during the course of the study.
• Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.
• Recurrent ACS event within 2 weeks prior to randomization.
• Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Northeast Arkansas Baptist Clinic

Jonesboro, Arkansas, United States

Central Cardiology Medical Center

Bakersfield, California, United States

The Heart Group Cardiovascular Associates Inc

Fresno, California, United States

Mission Heritage Medical Group

Mission Viejo, California, United States

Northbay Clinical Research LLC

Santa Rosa, California, United States

Clinnova Research Solutions

Torrance, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Interv Cardiology Med Grp

West Hills, California, United States

Aurora Denver Cardiology Associates

Aurora, Colorado, United States

Colorado Springs Cardiology

Colorado Springs, Colorado, United States

Colorado Heart and Vascular

Lakewood, Colorado, United States

Cardiology Ass of Fairfield County

Stamford, Connecticut, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

George Washington Univ Medical Ctr

Washington D.C., District of Columbia, United States

Nova Clinical Research LLC

Bradenton, Florida, United States

Teradan Clinical trials LLC

Brandon, Florida, United States

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, United States

Cardiology Research Associates

Daytona Beach, Florida, United States

Holy Cross Hospital Inc

Fort Lauderdale, Florida, United States

Baptist Health Research Institute

Jacksonville, Florida, United States

Reliant Medical Research

Miami, Florida, United States

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States

Innovation Medical Group LLC

Palmetto Bay, Florida, United States

Cardiology Consultants

Pensacola, Florida, United States

Theia Clinical Research Ctrs LLC

Tampa, Florida, United States

Morehouse School Of Medicine

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Ellipsis Group

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Northwest Heart Clinical Rsrch LLC

Arlington Heights, Illinois, United States

AMITA Heart and Vascular Group

Hinsdale, Illinois, United States

Franciscan Health Services Research Center

Indianapolis, Indiana, United States

Cardiovascular Research Of Northwest Indiana, Llc

Munster, Indiana, United States

Iowa Heart Center

Des Moines, Iowa, United States

Midwest Heart and Vascular Spec

Overland Park, Kansas, United States

Tidal Health Peninsula Regional Inc

Salisbury, Maryland, United States

Sparrow Clincal Research Institute

Lansing, Michigan, United States

MidMichigan Physicians Group

Midland, Michigan, United States

St Marys of Ascension Research

Saginaw, Michigan, United States

Trinity Health Michigan Heart

Ypsilanti, Michigan, United States

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Cardiology Associates of North MS

Tupelo, Mississippi, United States

St Louis Heart and Vascular

St Louis, Missouri, United States

Bryan LGH Heart Inst Intigrated Cardiology Group

Lincoln, Nebraska, United States

Meridian Clinical Research

Lincoln, Nebraska, United States

Advanced Heart Care, LLC

Bridgewater, New Jersey, United States

Cardiovas Assoc of Delaware Valley

Elmer, New Jersey, United States

Inspira Medical Cent Mullica Hill

Mullica Hill, New Jersey, United States

Capital Cardiology Associates

Albany, New York, United States

University At Buffalo

Buffalo, New York, United States

Bassett Medical Center

Cooperstown, New York, United States

Jamaica Hospital Medical Center

Jamaica, New York, United States

Northwell Health

Manhasset, New York, United States

Laurelton Heart Specialist PC

Rosedale, New York, United States

Cary Research Group

Cary, North Carolina, United States

Moses Cone Hospital-Lebauer CV Research Foundation

Greensboro, North Carolina, United States

Clinical Trials Of America LLC

Lenoir, North Carolina, United States

Pinehurst Medical Clinic

Pinehurst, North Carolina, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

University of Toledo

Toledo, Ohio, United States

St John Health System

Bartlesville, Oklahoma, United States

Bend Memorial Clinic

Bend, Oregon, United States

University of Pittsburgh Medical Center HABOT

Erie, Pennsylvania, United States

Lancaster General Health

Lancaster, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Guthrie Clinic

Sayre, Pennsylvania, United States

Monument Health Clinical Research

Rapid City, South Dakota, United States

Covenant Medical Group

Knoxville, Tennessee, United States

Baylor Scott and White Heart and Vascular Hospital

Dallas, Texas, United States

Vilo Research Group LLC

Houston, Texas, United States

Texas Heart Medical Group

Houston, Texas, United States

UT Physicians Memorial Hermann

Houston, Texas, United States

Northwest Houston Cardiology PA

Houston, Texas, United States

West Houston Area Clinical Trial Consultants

Houston, Texas, United States

The Heart Institute of East Texas

Lufkin, Texas, United States

CardioVoyage LLC

McKinney, Texas, United States

Research Group of North Texas

Sunnyvale, Texas, United States

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

TPMG Clinical Research

Newport News, Virginia, United States

York Clinical Research

Norfolk, Virginia, United States

Dominion Medical Associates

Richmond, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

Selma Medical Associates

Winchester, Virginia, United States

MultiCare Institute for Research and Innovation

Tacoma, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2749

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

CKJX839A1US01

Identifier Type: -

Identifier Source: org_study_id