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New drug inclisiran aims to slash cholesterol after heart attacks

NCT ID NCT04873934

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a drug called inclisiran to standard care helps lower 'bad' LDL cholesterol more effectively in people who recently had a heart attack. About 400 participants received either the new care pathway including inclisiran or usual care alone. The goal was to see if more patients could reach healthy cholesterol levels and reduce their future heart risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inclisiran (a drug that lowers LDL cholesterol)
What this could lead to
If successful, this approach could help heart attack patients achieve better cholesterol control, reducing their risk of future heart problems.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The benefit may be modest, and inclisiran requires injections, which some may find inconvenient.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

400 people

The number who actually took part.

Started

Jun 2021

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome atherosclerosis Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndrome

Contacts and locations

Locations

  • AMITA Heart and Vascular Group

    Hinsdale, Illinois, 60521, United States

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey, 08807, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Aultman Hospital

    Canton, Ohio, 44710, United States

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012, United States

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207, United States

  • Bassett Medical Center

    Cooperstown, New York, 13326, United States

  • Baylor Scott and White Heart and Vascular Hospital

    Dallas, Texas, 75226, United States

  • Bend Memorial Clinic

    Bend, Oregon, 97701, United States

  • Bryan LGH Heart Inst Intigrated Cardiology Group

    Lincoln, Nebraska, 68506, United States

  • Capital Cardiology Associates

    Albany, New York, 12211, United States

  • CardioVoyage LLC

    McKinney, Texas, 75071, United States

  • Cardiology Ass of Fairfield County

    Stamford, Connecticut, 06905, United States

  • Cardiology Associates of North MS

    Tupelo, Mississippi, 38801, United States

  • Cardiology Consultants

    Pensacola, Florida, 32501, United States

  • Cardiology Research Associates

    Daytona Beach, Florida, 32117, United States

  • Cardiovas Assoc of Delaware Valley

    Elmer, New Jersey, 08318, United States

  • Cardiovascular Research Of Northwest Indiana, Llc

    Munster, Indiana, 46321, United States

  • Carilion Clinic

    Roanoke, Virginia, 24013, United States

  • Cary Research Group

    Cary, North Carolina, 27511, United States

  • CentraCare Heart and Vascular Center

    Saint Cloud, Minnesota, 56303, United States

  • Central Cardiology Medical Center

    Bakersfield, California, 93308, United States

  • Clearwater Cardiovascular and Interventional Consultants

    Clearwater, Florida, 33756, United States

  • Clinical Trials Of America LLC

    Lenoir, North Carolina, 28645, United States

  • Clinnova Research Solutions

    Torrance, California, 90277, United States

  • Colorado Heart and Vascular

    Lakewood, Colorado, 80228, United States

  • Colorado Springs Cardiology

    Colorado Springs, Colorado, 80907, United States

  • Covenant Medical Group

    Knoxville, Tennessee, 37916, United States

  • Dominion Medical Associates

    Richmond, Virginia, 23219, United States

  • Ellipsis Group

    Atlanta, Georgia, 30342, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Franciscan Health Services Research Center

    Indianapolis, Indiana, 46237, United States

  • George Washington Univ Medical Ctr

    Washington D.C., District of Columbia, 20037, United States

  • Guthrie Clinic

    Sayre, Pennsylvania, 18840, United States

  • Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Holy Cross Hospital Inc

    Fort Lauderdale, Florida, 33308, United States

  • Innovation Medical Group LLC

    Palmetto Bay, Florida, 33157, United States

  • Inpatient Research Clinical LLC

    Miami Lakes, Florida, 33014, United States

  • Inspira Medical Cent Mullica Hill

    Mullica Hill, New Jersey, 08062, United States

  • Intermountain Medical Center

    Murray, Utah, 84107, United States

  • Interv Cardiology Med Grp

    West Hills, California, 91307, United States

  • Iowa Heart Center

    Des Moines, Iowa, 50314, United States

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216, United States

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418, United States

  • Lancaster General Health

    Lancaster, Pennsylvania, 17602, United States

  • Laurelton Heart Specialist PC

    Rosedale, New York, 11422, United States

  • Meridian Clinical Research

    Lincoln, Nebraska, 68506, United States

  • MidMichigan Physicians Group

    Midland, Michigan, 48640, United States

  • Midwest Heart and Vascular Spec

    Overland Park, Kansas, 66211, United States

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • Mission Heritage Medical Group

    Mission Viejo, California, 92691, United States

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701, United States

  • Morehouse School Of Medicine

    Atlanta, Georgia, 30310, United States

  • Moses Cone Hospital-Lebauer CV Research Foundation

    Greensboro, North Carolina, 27403, United States

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington, 98405, United States

  • Northbay Clinical Research LLC

    Santa Rosa, California, 95405, United States

  • Northeast Arkansas Baptist Clinic

    Jonesboro, Arkansas, 72401, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Northwest Heart Clinical Rsrch LLC

    Arlington Heights, Illinois, 60005, United States

  • Northwest Houston Cardiology PA

    Houston, Texas, 77070, United States

  • Nova Clinical Research LLC

    Bradenton, Florida, 34209, United States

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 28374, United States

  • Reliant Medical Research

    Miami, Florida, 33165, United States

  • Research Group of North Texas

    Sunnyvale, Texas, 75182, United States

  • Selma Medical Associates

    Winchester, Virginia, 22601, United States

  • Sparrow Clincal Research Institute

    Lansing, Michigan, 48912, United States

  • St John Health System

    Bartlesville, Oklahoma, 74006, United States

  • St Louis Heart and Vascular

    St Louis, Missouri, 63136, United States

  • St Marys of Ascension Research

    Saginaw, Michigan, 48601, United States

  • TPMG Clinical Research

    Newport News, Virginia, 23608, United States

  • Teradan Clinical trials LLC

    Brandon, Florida, 33511, United States

  • Texas Heart Medical Group

    Houston, Texas, 77030, United States

  • The Heart Group Cardiovascular Associates Inc

    Fresno, California, 93720, United States

  • The Heart Institute of East Texas

    Lufkin, Texas, 75904, United States

  • Theia Clinical Research Ctrs LLC

    Tampa, Florida, 33613, United States

  • Tidal Health Peninsula Regional Inc

    Salisbury, Maryland, 21804, United States

  • Trinity Health Michigan Heart

    Ypsilanti, Michigan, 48197, United States

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701, United States

  • UT Physicians Memorial Hermann

    Houston, Texas, 77030, United States

  • University At Buffalo

    Buffalo, New York, 14203, United States

  • University of Pittsburgh Medical Center HABOT

    Erie, Pennsylvania, 16550, United States

  • University of Toledo

    Toledo, Ohio, 43614, United States

  • Vilo Research Group LLC

    Houston, Texas, 77017, United States

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • West Houston Area Clinical Trial Consultants

    Houston, Texas, 77094, United States

  • York Clinical Research

    Norfolk, Virginia, 23504, United States

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