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)
V-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)
1 other identifier
interventional
450
1 country
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2021
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
June 18, 2021
CompletedStudy Start
First participant enrolled
June 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2023
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedMay 16, 2025
May 1, 2025
2.2 years
June 11, 2021
August 20, 2024
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in LDL-C
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) of an "inclisiran first" implementation strategy compared to usual care at Day 330.
Baseline, Day 330
Percentage of Participants Who Discontinued Statin Therapy
Percentage of patients who discontinued statin therapy ≥ 30 days before the end-of-study visit of an "inclisiran first" implementation strategy compared to usual care, for patients in the FAS excluding those with a medical history of statin intolerance.
Day 330
Secondary Outcomes (13)
Absolute Change From Baseline in LDL-C
Baseline, Day 330
Average Percent Change From Baseline in LDL-C Levels Across Visits
Up to 330 Days
Average Absolute Change From Baseline in LDL-C Levels Across Visits
Up to 330 days
Percentage of Participants Achieving ≥ 50% Reduction From Baseline in LDL-C
Baseline, Day 330
Percentage of Participants Achieving LDL-C < 100 mg/dL.
Day 330
- +8 more secondary outcomes
Study Arms (2)
Inclisiran First
EXPERIMENTALInclisiran sodium 300 mg 1.5 ml (equivalent to 284 mg of inclisiran) + usual care
Usual Care
NO INTERVENTIONTreating physicians were recommended to treat patients in accordance with the 2018 ACC/AHA guidelines
Interventions
Inclisiran sodium 300 mg/1.5 ml (equivalent to 284 mg inclisiran liquid) in prefilled syringe (PFS).
Eligibility Criteria
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
ARcare Center for Clinical Research .
Little Rock, Arkansas, 72205, United States
ARcare Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Keck Medical Center USC .
Los Angeles, California, 90033, United States
d-b-a Greenwich Cardio Assoc CLCZ696BUS08
Greenwich, Connecticut, 06830, United States
Cardiology Ass of Fairfield County .
Stamford, Connecticut, 06905, United States
Integrative Research Associates Inc
Fort Lauderdale, Florida, 33312, United States
Elite Cardiac Research Center .
Hialeah, Florida, 33012, United States
University of Florida Health Science Center .
Jacksonville, Florida, 32209, United States
Jacksonville Ctr for Clin Rea Encore Research Group
Jacksonville, Florida, 32216, United States
Internal Medicine and Cardiology
Kissimmee, Florida, 34741, United States
Gateway Cardiology PC CACZ885M2301_Younis
Jerseyville, Illinois, 62052, United States
Affinity Health Corp
Oak Brook, Illinois, 60523, United States
Northwestern Medicine Northwestern University .
Winfield, Illinois, 60190, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
St Elizabeth Healthcare .
Edgewood, Kentucky, 41017, United States
Alexandria Cardiology Clinic .
Alexandria, Louisiana, 71301, United States
Medstar Health Research Institute .
Baltimore, Maryland, 21218, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, 21239, United States
Bryan LGH Heart Inst Intigrated Cardiology Group .
Lincoln, Nebraska, 68506, United States
Inspira Health Network The Heart House
Elmer, New Jersey, 08318, United States
New Jersey Heart
Linden, New Jersey, 07036, United States
New York Presbyterian Queens .
Flushing, New York, 11355, United States
New York Presbyterian Hospital .
New York, New York, 10021, United States
State Uni of NY at Stony Brook .
Stony Brook, New York, 11794-3362, United States
Montefiore Hospital .
The Bronx, New York, 10467 2490, United States
Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Capital Area Research LLC Suite 330
Newport, Pennsylvania, 17074, United States
Capital Area Research
Newport, Pennsylvania, 17074, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067, United States
Alliance for Multispecialty Res LLC
Nashville, Tennessee, 37203, United States
Cypress Heart and Vascular Center
Cypress, Texas, 77429, United States
NW Houston Neuro Comp Sleep Med Ctr
Cypress, Texas, 77429, United States
Primecare Medical Group
Houston, Texas, 77024, United States
Synergy Group Medical LLC .
Houston, Texas, 77061, United States
Synergy Group Medical LLC
Houston, Texas, 77061, United States
Northwest Houston Cardiology PA .
Houston, Texas, 77070, United States
Synergy Groups Medical LLC
Missouri City, Texas, 77459, United States
Bay Area Heart Ace Clinical Resh Gp .
Webster, Texas, 77598, United States
Centra Health .
Lynchburg, Virginia, 24501, United States
National Clinical Research .
Richmond, Virginia, 23294, United States
Exemplar Research Inc .
Morgantown, West Virginia, 26501, United States
Marshfield Medical Clinic .
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic Health System
Weston, Wisconsin, 54476, United States
Related Publications (1)
Koren MJ, Rodriguez F, East C, Toth PP, Watwe V, Abbas CA, Sarwat S, Kleeman K, Kumar B, Ali Y, Jaffrani N. An "Inclisiran First" Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease. J Am Coll Cardiol. 2024 May 21;83(20):1939-1952. doi: 10.1016/j.jacc.2024.03.382. Epub 2024 Apr 7.
PMID: 38593947DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2021
First Posted
June 18, 2021
Study Start
June 25, 2021
Primary Completion
September 15, 2023
Study Completion
September 15, 2023
Last Updated
May 16, 2025
Results First Posted
September 19, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
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