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)
1 other identifier
interventional
400
1 country
88
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2021
Typical duration for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedStudy Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2024
CompletedResults Posted
Study results publicly available
August 21, 2025
CompletedOctober 16, 2025
October 1, 2025
3.1 years
April 30, 2021
August 1, 2025
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (11)
Absolute Change From Baseline in LDL-C
Baseline, Day 90, Day 270 and Day 330
Average Percent Change From Baseline in LDL-C Levels
Baseline, from Day 90 to Day 330
Average Absolute Change From Baseline in LDL-C Levels
Baseline, From Day 90 to Day 330
Achieving ≥50% Reduction From Baseline in LDL-C
Baseline, Day 330
Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL
Day 330
- +6 more secondary outcomes
Study Arms (2)
Inclisiran with Usual Care
EXPERIMENTALInclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Usual Care
NO INTERVENTIONUsual Care Alone
Interventions
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 halfË—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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
Northeast Arkansas Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Central Cardiology Medical Center
Bakersfield, California, 93308, United States
The Heart Group Cardiovascular Associates Inc
Fresno, California, 93720, United States
Mission Heritage Medical Group
Mission Viejo, California, 92691, United States
Northbay Clinical Research LLC
Santa Rosa, California, 95405, United States
Clinnova Research Solutions
Torrance, California, 90277, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Interv Cardiology Med Grp
West Hills, California, 91307, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
Colorado Springs Cardiology
Colorado Springs, Colorado, 80907, United States
Colorado Heart and Vascular
Lakewood, Colorado, 80228, United States
Cardiology Ass of Fairfield County
Stamford, Connecticut, 06905, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
George Washington Univ Medical Ctr
Washington D.C., District of Columbia, 20037, United States
Nova Clinical Research LLC
Bradenton, Florida, 34209, United States
Teradan Clinical trials LLC
Brandon, Florida, 33511, United States
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, 33756, United States
Cardiology Research Associates
Daytona Beach, Florida, 32117, United States
Holy Cross Hospital Inc
Fort Lauderdale, Florida, 33308, United States
Baptist Health Research Institute
Jacksonville, Florida, 32207, United States
Reliant Medical Research
Miami, Florida, 33165, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014, United States
Innovation Medical Group LLC
Palmetto Bay, Florida, 33157, United States
Cardiology Consultants
Pensacola, Florida, 32501, United States
Theia Clinical Research Ctrs LLC
Tampa, Florida, 33613, United States
Morehouse School Of Medicine
Atlanta, Georgia, 30310, United States
Emory University
Atlanta, Georgia, 30322, United States
Ellipsis Group
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwest Heart Clinical Rsrch LLC
Arlington Heights, Illinois, 60005, United States
AMITA Heart and Vascular Group
Hinsdale, Illinois, 60521, United States
Franciscan Health Services Research Center
Indianapolis, Indiana, 46237, United States
Cardiovascular Research Of Northwest Indiana, Llc
Munster, Indiana, 46321, United States
Iowa Heart Center
Des Moines, Iowa, 50314, United States
Midwest Heart and Vascular Spec
Overland Park, Kansas, 66211, United States
Tidal Health Peninsula Regional Inc
Salisbury, Maryland, 21804, United States
Sparrow Clincal Research Institute
Lansing, Michigan, 48912, United States
MidMichigan Physicians Group
Midland, Michigan, 48640, United States
St Marys of Ascension Research
Saginaw, Michigan, 48601, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, 56303, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
Cardiology Associates of North MS
Tupelo, Mississippi, 38801, United States
St Louis Heart and Vascular
St Louis, Missouri, 63136, United States
Bryan LGH Heart Inst Intigrated Cardiology Group
Lincoln, Nebraska, 68506, United States
Meridian Clinical Research
Lincoln, Nebraska, 68506, United States
Advanced Heart Care, LLC
Bridgewater, New Jersey, 08807, United States
Cardiovas Assoc of Delaware Valley
Elmer, New Jersey, 08318, United States
Inspira Medical Cent Mullica Hill
Mullica Hill, New Jersey, 08062, United States
Capital Cardiology Associates
Albany, New York, 12211, United States
University At Buffalo
Buffalo, New York, 14203, United States
Bassett Medical Center
Cooperstown, New York, 13326, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Northwell Health
Manhasset, New York, 11030, United States
Laurelton Heart Specialist PC
Rosedale, New York, 11422, United States
Cary Research Group
Cary, North Carolina, 27511, United States
Moses Cone Hospital-Lebauer CV Research Foundation
Greensboro, North Carolina, 27403, United States
Clinical Trials Of America LLC
Lenoir, North Carolina, 28645, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Aultman Hospital
Canton, Ohio, 44710, United States
University of Toledo
Toledo, Ohio, 43614, United States
St John Health System
Bartlesville, Oklahoma, 74006, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
University of Pittsburgh Medical Center HABOT
Erie, Pennsylvania, 16550, United States
Lancaster General Health
Lancaster, Pennsylvania, 17602, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Guthrie Clinic
Sayre, Pennsylvania, 18840, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
Covenant Medical Group
Knoxville, Tennessee, 37916, United States
Baylor Scott and White Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Vilo Research Group LLC
Houston, Texas, 77017, United States
Texas Heart Medical Group
Houston, Texas, 77030, United States
UT Physicians Memorial Hermann
Houston, Texas, 77030, United States
Northwest Houston Cardiology PA
Houston, Texas, 77070, United States
West Houston Area Clinical Trial Consultants
Houston, Texas, 77094, United States
The Heart Institute of East Texas
Lufkin, Texas, 75904, United States
CardioVoyage LLC
McKinney, Texas, 75071, United States
Research Group of North Texas
Sunnyvale, Texas, 75182, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
TPMG Clinical Research
Newport News, Virginia, 23608, United States
York Clinical Research
Norfolk, Virginia, 23504, United States
Dominion Medical Associates
Richmond, Virginia, 23219, United States
Carilion Clinic
Roanoke, Virginia, 24013, United States
Selma Medical Associates
Winchester, Virginia, 22601, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2021
First Posted
May 5, 2021
Study Start
June 24, 2021
Primary Completion
August 7, 2024
Study Completion
August 7, 2024
Last Updated
October 16, 2025
Results First Posted
August 21, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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