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Acute Coronary SyndromePhase 3V-INCEPTIONNCT04873934

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

A Phase 3 study testing Inclisiran in people with Acute Coronary Syndrome, run by Novartis Pharmaceuticals at 88 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Inclisiran
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
88 sitesUnited States
Study dates
24 Jun 2021to 7 Aug 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

88 sites in 1 country.

88 sites in 1 country

United States88 sites

  • Capital Cardiology Associates

    Albany, New York, 12211

  • Northwest Heart Clinical Rsrch LLC

    Arlington Heights, Illinois, 60005

  • Morehouse School Of Medicine

    Atlanta, Georgia, 30310

  • Emory University

    Atlanta, Georgia, 30322

  • Ellipsis Group

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012

  • Central Cardiology Medical Center

    Bakersfield, California, 93308

  • St John Health System

    Bartlesville, Oklahoma, 74006

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • Nova Clinical Research LLC

    Bradenton, Florida, 34209

  • Teradan Clinical trials LLC

    Brandon, Florida, 33511

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey, 08807

  • University At Buffalo

    Buffalo, New York, 14203

  • Aultman Hospital

    Canton, Ohio, 44710

  • Cary Research Group

    Cary, North Carolina, 27511

  • Clearwater Cardiovascular and Interventional Consultants

    Clearwater, Florida, 33756

  • Colorado Springs Cardiology

    Colorado Springs, Colorado, 80907

  • Bassett Medical Center

    Cooperstown, New York, 13326

  • Baylor Scott and White Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Cardiology Research Associates

    Daytona Beach, Florida, 32117

  • Iowa Heart Center

    Des Moines, Iowa, 50314

  • Cardiovas Assoc of Delaware Valley

    Elmer, New Jersey, 08318

  • University of Pittsburgh Medical Center HABOT

    Erie, Pennsylvania, 16550

  • Holy Cross Hospital Inc

    Fort Lauderdale, Florida, 33308

  • The Heart Group Cardiovascular Associates Inc

    Fresno, California, 93720

  • Moses Cone Hospital-Lebauer CV Research Foundation

    Greensboro, North Carolina, 27403

  • AMITA Heart and Vascular Group

    Hinsdale, Illinois, 60521

  • Vilo Research Group LLC

    Houston, Texas, 77017

  • Texas Heart Medical Group

    Houston, Texas, 77030

  • UT Physicians Memorial Hermann

    Houston, Texas, 77030

  • Northwest Houston Cardiology PA

    Houston, Texas, 77070

  • West Houston Area Clinical Trial Consultants

    Houston, Texas, 77094

  • Franciscan Health Services Research Center

    Indianapolis, Indiana, 46237

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Northeast Arkansas Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Covenant Medical Group

    Knoxville, Tennessee, 37916

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228

  • Lancaster General Health

    Lancaster, Pennsylvania, 17602

  • Sparrow Clincal Research Institute

    Lansing, Michigan, 48912

  • Clinical Trials Of America LLC

    Lenoir, North Carolina, 28645

  • Bryan LGH Heart Inst Intigrated Cardiology Group

    Lincoln, Nebraska, 68506

  • Meridian Clinical Research

    Lincoln, Nebraska, 68506

  • The Heart Institute of East Texas

    Lufkin, Texas, 75904

  • Northwell Health

    Manhasset, New York, 11030

  • CardioVoyage LLC

    McKinney, Texas, 75071

  • Reliant Medical Research

    Miami, Florida, 33165

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014

  • MidMichigan Physicians Group

    Midland, Michigan, 48640

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Mission Heritage Medical Group

    Mission Viejo, California, 92691

  • Inspira Medical Cent Mullica Hill

    Mullica Hill, New Jersey, 08062

  • Cardiovascular Research Of Northwest Indiana, Llc

    Munster, Indiana, 46321

  • Intermountain Medical Center

    Murray, Utah, 84107

  • TPMG Clinical Research

    Newport News, Virginia, 23608

  • York Clinical Research

    Norfolk, Virginia, 23504

  • Midwest Heart and Vascular Spec

    Overland Park, Kansas, 66211

  • Innovation Medical Group LLC

    Palmetto Bay, Florida, 33157

  • Cardiology Consultants

    Pensacola, Florida, 32501

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 28374

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • Dominion Medical Associates

    Richmond, Virginia, 23219

  • Carilion Clinic

    Roanoke, Virginia, 24013

  • Laurelton Heart Specialist PC

    Rosedale, New York, 11422

  • St Marys of Ascension Research

    Saginaw, Michigan, 48601

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303

  • Tidal Health Peninsula Regional Inc

    Salisbury, Maryland, 21804

  • Northbay Clinical Research LLC

    Santa Rosa, California, 95405

  • Guthrie Clinic

    Sayre, Pennsylvania, 18840

  • St Louis Heart and Vascular

    St Louis, Missouri, 63136

  • Cardiology Ass of Fairfield County

    Stamford, Connecticut, 06905

  • Research Group of North Texas

    Sunnyvale, Texas, 75182

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Theia Clinical Research Ctrs LLC

    Tampa, Florida, 33613

  • University of Toledo

    Toledo, Ohio, 43614

  • Clinnova Research Solutions

    Torrance, California, 90277

  • Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Cardiology Associates of North MS

    Tupelo, Mississippi, 38801

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • George Washington Univ Medical Ctr

    Washington D.C., District of Columbia, 20037

  • Interv Cardiology Med Grp

    West Hills, California, 91307

  • Selma Medical Associates

    Winchester, Virginia, 22601

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • Trinity Health Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: 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.

Read the 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

Being tested
Inclisiran
Keywords
Hyperlipidemia, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Lipid lowering therapies
Medical subject headings
Acute Coronary Syndrome, Hyperlipidemias, Atherosclerosis, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InclisiranDrug

    Also called KJX839

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

Study groups in NCT04873934
Study groupRoleWhat they receive
Inclisiran with Usual CareExperimentalInclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Receives: Drug: Inclisiran
Usual CareNo interventionUsual Care Alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline to Day 330 in LDL-C

    Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330

    Measured: Baseline and Day 330

  2. 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

    Measured: Day 330

Secondary outcomes (11)

  1. Absolute Change From Baseline in LDL-C

    Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) by visit

    Measured: Baseline, Day 90, Day 270 and Day 330

  2. 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

    Measured: Baseline, from Day 90 to Day 330

  3. 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

    Measured: Baseline, From Day 90 to Day 330

  4. 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

    Measured: Baseline, Day 330

  5. 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

    Measured: Day 330

  6. 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

    Measured: Baseline and Day 330

  7. 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

    Measured: Baseline and Day 330

  8. Absolute Change in Lp[a] From Baseline to Day 330

    Absolute change in lipoprotein(a) (Lp[a]) from baseline to Day 330

    Measured: Baseline and Day 330

  9. Intensity of Lipid Lowering Therapy

    Percentage of participants by intensity of lipid lowering therapy (dose decrease, increase or no change)

    Measured: Baseline and Day 330

  10. 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.

    Measured: Baseline through last date of participation, up to 330 Days

  11. 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.

    Measured: Baseline and Day 330

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study start24 Jun 2021
  3. Primary completion7 Aug 2024
  4. Study completion7 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04873934
Sponsor's protocol ID
CKJX839A1US01
Acronym
V-INCEPTION
Status last verified
Oct 2025
First submitted
30 Apr 2021
Last updated
16 Oct 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Knowlton KU, Navar AM, Anderson JL, Brown AS, Muhlestein JB, Kleeman K, Sarwat S, Abbas CA, Ramirez MA, Grines CL, Abo-Auda WS, Desai NR. Low-Density Lipoprotein Cholesterol Lowering With Inclisiran Plus Usual Care in Recent Acute Coronary Syndrome: VICTORION-INCEPTION, a Randomized, Controlled, Open-Label Trial. J Am Heart Assoc. 2026 May 19;15(10):e043655. doi: 10.1161/JAHA.125.043655. Epub 2026 May 14.

    PubMed 42132192

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inclisiran in people with Acute Coronary Syndrome, run by Novartis Pharmaceuticals at 88 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to Day 330 in LDL-C (time frame: Baseline and Day 330). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04873934, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.

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