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)

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)

ClinicalTrials.gov Identifier: NCT04929249

Novartis Reference Number: CKJX839A1US02

Last Update: Apr 07, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Atherosclerotic Cardiovascular Disease
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Jun 25, 2021
Completion date 
Jun 30, 2023
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Inclisiran
284 mg liquid in prefilled syringe (PFS), 1.5 ml inclisiran sodium (300 mg)

Eligibility Criteria

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
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
Persons directly involved in the conduct of 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

Study Locations

United States
Novartis Investigative Site
Recruiting
Little Rock, 72205
Arkansas
United States
Novartis Investigative Site
Recruiting
Greenwich, 06830
Connecticut
United States
Novartis Investigative Site
Recruiting
Stamford, 06905
Connecticut
United States
Novartis Investigative Site
Recruiting
Fort Lauderdale, 33312
Florida
United States
Novartis Investigative Site
Recruiting
Hialeah, 33012
Florida
United States
Novartis Investigative Site
Recruiting
Jacksonville, 32209
Florida
United States
Novartis Investigative Site
Recruiting
Jacksonville, 32216
Florida
United States
Novartis Investigative Site
Recruiting
Jerseyville, 62052
Illinois
United States
Novartis Investigative Site
Recruiting
Oak Brook, 60523
Illinois
United States
Novartis Investigative Site
Recruiting
Winfield, 60190
Illinois
United States
Novartis Investigative Site
Recruiting
Davenport, 52801
Iowa
United States
Novartis Investigative Site
Recruiting
Alexandria, 71301
Louisiana
United States
Novartis Investigative Site
Recruiting
Baltimore, 21218
Maryland
United States
Novartis Investigative Site
Recruiting
Elmer, 08318
New Jersey
United States
Novartis Investigative Site
Recruiting
Linden, 07036
New Jersey
United States
Novartis Investigative Site
Recruiting
Camp Hill, 17011
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Newport, 17074
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Yardley, 19067
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Cypress, 77429
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77036
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77070
Texas
United States
Novartis Investigative Site
Recruiting
Webster, 77598
Texas
United States
Novartis Investigative Site
Recruiting
Lynchburg, 24501
Virginia
United States
Novartis Investigative Site
Recruiting
Richmond, 23294
Virginia
United States
Novartis Investigative Site
Recruiting
Morgantown, 26501
West Virginia
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
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Novartis Pharmaceuticals
Phone: 

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