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

A Randomized, Controlled, Multicenter, Open-label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome (VICTORION-INCEPTION)

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Inclisiran

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

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Northeast Arkansas Baptist Clinic
  • California
    • Bakersfield, California, United States, 93308
      • Central Cardiology Medical Center
    • Fresno, California, United States, 93720
      • The Heart Group Cardiovascular Associates Inc
    • Mission Viejo, California, United States, 92691
      • Mission Heritage Medical Group
    • Santa Rosa, California, United States, 95405
      • NorthBay Clinical Research LLC
    • Torrance, California, United States, 90502
      • Harbor-UCLA Medical Center
    • Torrance, California, United States, 90277
      • Clinnova Research Solutions
    • West Hills, California, United States, 91307
      • Interv Cardiology Med Grp
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Aurora Denver Cardiology Associates
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Cardiology
    • Lakewood, Colorado, United States, 80228
      • Colorado Heart and Vascular
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Cardiology Ass of Fairfield County
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Washington Hospital Center
    • Washington D.C., District of Columbia, United States, 20037
      • George Washington Univ Medical Ctr
  • Florida
    • Bradenton, Florida, United States, 34209
      • Nova Clinical Research LLC
    • Brandon, Florida, United States, 33511
      • Teradan Clinical trials LLC
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular and Interventional Consultants
    • Daytona Beach, Florida, United States, 32117
      • Cardiology Research Associates
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital Inc
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Research Institute
    • Miami, Florida, United States, 33165
      • Reliant Medical Research
    • Miami Lakes, Florida, United States, 33014
      • Inpatient Research Clinical LLC
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Group LLC
    • Pensacola, Florida, United States, 32501
      • Cardiology Consultants
    • Tampa, Florida, United States, 33613
      • Theia Clinical Research Ctrs LLC
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Atlanta, Georgia, United States, 30310
      • Morehouse School of Medicine
    • Atlanta, Georgia, United States, 30342
      • Ellipsis Group
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Heart Clinical Rsrch LLC
    • Hinsdale, Illinois, United States, 60521
      • AMITA Heart and Vascular Group
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Franciscan Health Services Research Center
    • Munster, Indiana, United States, 46321
      • Cardiovascular Research of Northwest Indiana, LLC
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Heart Center
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Midwest Heart and Vascular Spec
  • Maryland
    • Salisbury, Maryland, United States, 21804
      • Tidal Health Peninsula Regional Inc
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Clincal Research Institute
    • Midland, Michigan, United States, 48640
      • MidMichigan Physicians Group
    • Saginaw, Michigan, United States, 48601
      • St Marys of Ascension Research
    • Ypsilanti, Michigan, United States, 48197
      • Trinity Health Michigan Heart
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
    • Saint Cloud, Minnesota, United States, 56303
      • Centracare Heart and Vascular Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates of North MS
  • Missouri
    • St Louis, Missouri, United States, 63136
      • St Louis Heart and Vascular
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan LGH Heart Inst Intigrated Cardiology Group
    • Lincoln, Nebraska, United States, 68506
      • Meridian Clinical Research
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Advanced Heart Care, LLC
    • Elmer, New Jersey, United States, 08318
      • Cardiovas Assoc of Delaware Valley
    • Mullica Hill, New Jersey, United States, 08062
      • Inspira Medical Cent Mullica Hill
  • New York
    • Albany, New York, United States, 12211
      • Capital Cardiology Associates
    • Buffalo, New York, United States, 14203
      • University at Buffalo
    • Cooperstown, New York, United States, 13326
      • Bassett Medical Center
    • Jamaica, New York, United States, 11418
      • Jamaica Hospital Medical Center
    • Manhasset, New York, United States, 11030
      • Northwell Health
    • Rosedale, New York, United States, 11422
      • Laurelton Heart Specialist PC
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • Cary Research Group
    • Greensboro, North Carolina, United States, 27403
      • Moses Cone Hospital-Lebauer CV Research Foundation
    • Lenoir, North Carolina, United States, 28645
      • Clinical Trials of America LLC
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Medical Clinic
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Toledo, Ohio, United States, 43614
      • University of Toledo
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • St John Health System
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16550
      • University of Pittsburgh Medical Center HABOT
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Health
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Clinic
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Covenant Medical Group
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Scott and White Heart and Vascular Hospital
    • Houston, Texas, United States, 77094
      • West Houston Area Clinical Trial Consultants
    • Houston, Texas, United States, 77030
      • UT Physicians Memorial Hermann
    • Houston, Texas, United States, 77017
      • Vilo Research Group LLC
    • Houston, Texas, United States, 77030
      • Texas Heart Medical Group
    • Houston, Texas, United States, 77070
      • Northwest Houston Cardiology PA
    • Lufkin, Texas, United States, 75904
      • The Heart Institute of East Texas
    • McKinney, Texas, United States, 75071
      • CardioVoyage LLC
    • Sunnyvale, Texas, United States, 75182
      • Research Group of North Texas
    • Tyler, Texas, United States, 75701
      • Tyler Cardiovascular Consultants
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Newport News, Virginia, United States, 23608
      • TPMG Clinical Research
    • Norfolk, Virginia, United States, 23504
      • York Clinical Research
    • Richmond, Virginia, United States, 23219
      • Dominion Medical Associates
    • Roanoke, Virginia, United States, 24013
      • Carilion Clinic
    • Winchester, Virginia, United States, 22601
      • Selma Medical Associates
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Institute for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inclisiran with Usual Care; Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)	Drug: Inclisiran; Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran); Other Names: KJX839
No Intervention: Usual Care; Usual Care Alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline to Day 330 in LDL-C	Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330	Baseline and Day 330
Achievement of LDL-C < 70 mg/dL at Day 330	Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) < 70 mg/dL at Day 330	Day 330

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in LDL-C	Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) by visit	Baseline, Day 90, Day 270 and Day 330
Average Percent Change From Baseline in LDL-C Levels	Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit	Baseline, from Day 90 to Day 330
Average Absolute Change From Baseline in LDL-C Levels	Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit	Baseline, From Day 90 to Day 330
Achieving ≥50% Reduction From Baseline in LDL-C	Percentage of participants achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Day 330	Baseline, Day 330
Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL	Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) <100 mg/dL (among the subset of participants with baseline LDL-C >= 100 mg/dL) and LDL-C < 55 mg/dL at Day 330	Day 330
Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330	Percent change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, lipoprotein(a) (Lp[a]), HDL-C and triglycerides from baseline to Day 330	Baseline and Day 330
Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330	Absolute change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, HDL-C and triglycerides from baseline to Day 330	Baseline and Day 330
Absolute Change in Lp[a] From Baseline to Day 330	Absolute change in lipoprotein(a) (Lp[a]) from baseline to Day 330	Baseline and Day 330
Intensity of Lipid Lowering Therapy	Percentage of participants by intensity of lipid lowering therapy (dose decrease, increase or no change)	Baseline and Day 330
Proportion of Days Covered	Total number of days on either statin, ezetimibe, or PCSK9 inhibiting monoclonal antibody therapies divided by total number of study days. If a participant did not take any of the 3 medications, then the total number of days was assumed to be zero.	Baseline through last date of participation, up to 330 Days
Discontinuation of Statin Therapy	Percentage of participants discontinuing statin therapy. Discontinuation of statin therapy was defined as no statin use ≥ 30 days before the end-of-study visit. Participants for whom it could not be ascertained that they were on statin therapy at the end of study or who discontinued from the study early were assumed to have discontinued statin therapy.	Baseline and Day 330

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Actual): August 7, 2024
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: April 30, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Estimated): October 16, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Hypercholesterolemia; Hyperlipidemia; Lipid lowering therapies; Atherosclerotic Cardiovascular Disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Nutritional and Metabolic Diseases; Hypercholesterolemia; Atherosclerosis; Acute Coronary Syndrome; Hyperlipidemias; ALN-PCS
• Other Study ID Numbers: CKJX839A1US01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No