A Randomized Study to Evaluate the Effect of an "Inclisiran First" Implementation Strategy Compared to Usual Care in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE)

Completed · Phase 3

Conditions studied: Atherosclerotic Cardiovascular Disease

In brief

The purpose of this study was to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy alone) compared to usual care in an atherosclerotic cardiovascular disease (ASCVD) population.

Key facts

Study ID: NCT04929249
Run by: Novartis Pharmaceuticals
People needed: 450
Starts: 2021-06-25
Expected to finish: 2023-09-15
Last updated by the study team: 2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Participants meeting any of the following criteria are not eligible for inclusion in this study.
Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study
An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results
New York Heart Association (NYHA) class III or IV heart failure or last known left ventricular ejection fraction <30%
Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening
Major adverse cardiovascular event within 6 months prior to randomization
Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization despite antihypertensive therapy
Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years
History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the two years prior to randomization
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of investigational drug. Basic contraception methods include:
Total abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
Male sterilization (at least 6 m prior to screening). For female participants in the study, the vasectomized male partner should be the sole partner for that participant
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps)
Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
Known history of alcohol and/or drug abuse within the last 5 years (occasional casual users of illicit drugs in the opinion of the investigators are not excluded)
Treatment with other investigational products or devices within 30 days or five half-lives of the screening visit, whichever is longer
History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
Planned use of other investigational products or devices during the course of the study
Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
Participants who are unable to communicate or to cooperate with the investigator
Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency)
Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study - including potential participants who indicate that their participation is contingent on receiving inclisiran)
Have any medical or surgical condition, which in the opinion of the investigator would put the participant at increased risk from participating in the study

Where it is running

ARcare Center for Clinical Research . — Little Rock, Arkansas, United States
ARcare Center for Clinical Research — Little Rock, Arkansas, United States
Keck Medical Center USC . — Los Angeles, California, United States
d-b-a Greenwich Cardio Assoc CLCZ696BUS08 — Greenwich, Connecticut, United States
Cardiology Ass of Fairfield County . — Stamford, Connecticut, United States
Integrative Research Associates Inc — Fort Lauderdale, Florida, United States
Elite Cardiac Research Center . — Hialeah, Florida, United States
University of Florida Health Science Center . — Jacksonville, Florida, United States
Jacksonville Ctr for Clin Rea Encore Research Group — Jacksonville, Florida, United States
Internal Medicine and Cardiology — Kissimmee, Florida, United States
Gateway Cardiology PC CACZ885M2301_Younis — Jerseyville, Illinois, United States
Affinity Health Corp — Oak Brook, Illinois, United States
Northwestern Medicine Northwestern University . — Winfield, Illinois, United States
Indiana University Health — Indianapolis, Indiana, United States
St Elizabeth Healthcare . — Edgewood, Kentucky, United States
Alexandria Cardiology Clinic . — Alexandria, Louisiana, United States
Medstar Health Research Institute . — Baltimore, Maryland, United States
MedStar Good Samaritan Hospital — Baltimore, Maryland, United States
Bryan LGH Heart Inst Intigrated Cardiology Group . — Lincoln, Nebraska, United States
Inspira Health Network The Heart House — Elmer, New Jersey, United States
New Jersey Heart — Linden, New Jersey, United States
New York Presbyterian Queens . — Flushing, New York, United States
New York Presbyterian Hospital . — New York, New York, United States
State Uni of NY at Stony Brook . — Stony Brook, New York, United States
Montefiore Hospital . — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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