A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an "Inclisiran First" Implementation Strategy to Usual Care on LDL Cholesterol (LDL-C) in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C (≥70 mg/dL) Despite Receiving Maximally Tolerated Statin Therapy (VICTORION-INITIATE) (V-INITIATE)

  • STATUS
    Recruiting
  • End date
    Sep 29, 2023
  • participants needed
    444
  • sponsor
    Novartis Pharmaceuticals
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Updated on 28 October 2022
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Summary

The purpose of this study is 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 ASCVD population.

Description

The study design will be a randomized, two-arm, parallel-group, open-label, multicenter, clinical trial comparing an "inclisiran first" implementation strategy to usual care in approximately 444 participants (1:1 randomization) with established ASCVD and elevated LDL-C (or non-HDL-C) despite treatment with maximally tolerated statin therapy.

The study will include male and female participants ≥18 years of age with a history of ASCVD (coronary heart disease, ischemic cerebrovascular disease or peripheral arterial disease) who have elevated LDL-C (≥70 mg/dL) or non-HDL-C (≥100 mg/dL) despite being treated with maximally tolerated statin therapy. A total of approximately 444 participants will be randomized to the "inclisiran first" implementation strategy or usual care in a 1:1 ratio at approximately 40 US sites.

Details
Condition Atherosclerotic Cardiovascular Disease
Treatment Inclisiran
Clinical Study IdentifierNCT04929249
SponsorNovartis Pharmaceuticals
Last Modified on28 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participants eligible for inclusion in this study must meet all of the
following criteria
Signed informed consent must be obtained prior to participation in the study
Males and females ≥18 years of age
History of ASCVD, documented by hospital records, claims data and/or prior laboratory/imaging assessments
Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
Fasting triglyceride <5.65 mmol/L (<500 mg/dL) at screening
Calculated glomerular filtration rate >30 mL/min by estimated glomerular filtration rate (eGFR) using standardized local clinical methodology
Participants should be on maximally tolerated statin therapy, as determined by the investigator, with no immediate plans to modify lipid lowering therapies. Statin intolerant patients are eligible if they had documented side effects on at least 2 different statins, including one at the lowest standard dose
Participants must be willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures

Exclusion Criteria

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
Major adverse cardiovascular event within 6 months prior to randomization
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
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
Participants who are unable to communicate or to cooperate with the investigator
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
Persons directly involved in the conduct of the study
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
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
Previous or current treatment (within 90 days of screening) with monoclonal antibodies
directed towards PCSK9 or ezetimibe
Active liver disease defined as any known current infectious, neoplastic, or metabolic
pathology of the liver or alanine aminotransferase (ALT) elevation >3x ULN, aspartate
aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation >2x ULN (except
patients with Gilbert's syndrome) at screening confirmed by a repeat measurement at
least one week apart
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