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V-INCEPTION: Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04873934
Collaborator
(none)
384
Enrollment
43
Locations
2
Arms
32.9
Anticipated Duration (Months)
8.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug,

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug,

Study Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled, Multicenter, Open-label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome(VICTORION-INCEPTION)
Actual Study Start Date :
Jun 24, 2021
Anticipated Primary Completion Date :
Jun 7, 2023
Anticipated Study Completion Date :
Mar 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Inclisiran with Usual Care

Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)

Drug: Inclisiran
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
Other Names:
  • KJX839

    		•
    No Intervention: Usual Care

    Usual Care Alone

    Outcome Measures

    Primary Outcome Measures

    1. Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) [Baseline and Day 330]

      Inclisiran compared to usual care in reducing LDL-C [percent change] at Day 330 (Year 1)

    2. Percentage (%) achieving change in low-density lipoprotein cholesterol (LDL-C) to <70 mg/dl [Baseline and Day 330]

      Inclisiran compared to usual care in achieving LDL-C reduction <70 mg/dl [percent achieved] at Day 330 (Year 1)

    Secondary Outcome Measures

    1. Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) [Baseline to Day 330]

      Inclisiran compared to usual care in reducing LDL-C [absolute change] at Day 330 (Year 1)

    2. Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit [Baseline, after Day 90 up to Day 330]

      Inclisiran compared to usual care on average percent change from baseline in LDL-C levels after Day 90 and up to Day 330

    3. Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit [Baseline, after Day 90 up to Day 330]

      Inclisiran compared to usual care on average absolute change from baseline in LDL-C levels after Day 90 and up to Day 330

    4. Achieving ≥ 50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) (yes, no) [Baseline, after Day 90 up to Day 330]

      Inclisiran compared to usual care on achieving ≥ 50% reduction from baseline in LDL-C after Day 90 and up to Day 330

    5. Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) targets (LDL-C < 100 mg/dL among the subset of participants with LDL-C ≥ 100 mg/dL at baseline, and LDL-C < 55 mg/dL) [Baseline, after Day 90 up to Day 330]

      Inclisiran compared to usual care on achieving LDL-C < 100 mg/dL (subset of LDL-C ≥ 100 mg/dL at baseline) and LDL-C <55 mg/dl after Day 90 and up to Day 330

    6. Percent change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol [Baseline and Day 330]

      Inclisiran compared to placebo in reducing Apo B, very low density lipoprotein (VLDL), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) [Lp(a)], non-high density lipoprotein cholesterol (non-HDL-C), and total cholesterol over time

    7. Absolute change in apolipoprotein B, very low density lipoprotein, high density lipoprotein cholesterol, lipoprotein (a), non-high density lipoprotein cholesterol, and total cholesterol [Baseline and Day 330]

      Inclisiran compared to placebo in reducing Apo B, very low density lipoprotein (VLDL), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) [Lp(a)], non-high density lipoprotein cholesterol (non-HDL-C), and total cholesterol over time

    8. Measurement of the intensity of lipid lowering therapy (dose decrease, increase or no change) [Baseline and Day 330]

      Inclisiran compared to usual care on intensity of lipid lowering therapy over time

    9. Percentage of participants discontinuing statin therapy (i.e., no statin use ≥ 30 days before the end-of-study visit) [Baseline and Day 330]

      Inclisiran compared to usual care on discontinuation of statin therapy from baseline to Day 330

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 patients 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Bakersfield California United States 93308
    2 Novartis Investigative Site Fresno California United States 93720
    3 Novartis Investigative Site Mission Viejo California United States 92691
    4 Novartis Investigative Site Santa Rosa California United States 95405
    5 Novartis Investigative Site Torrance California United States 90277
    6 Novartis Investigative Site West Hills California United States 91307
    7 Novartis Investigative Site Colorado Springs Colorado United States 80907
    8 Novartis Investigative Site Stamford Connecticut United States 06905
    9 Novartis Investigative Site Daytona Beach Florida United States 32117
    10 Novartis Investigative Site Fort Lauderdale Florida United States 33308
    11 Novartis Investigative Site Gainesville Florida United States 32605
    12 Novartis Investigative Site Hialeah Florida United States 33013
    13 Novartis Investigative Site Palmetto Bay Florida United States 33157
    14 Novartis Investigative Site Tampa Florida United States 33613
    15 Novartis Investigative Site Arlington Heights Illinois United States 60005
    16 Novartis Investigative Site Hinsdale Illinois United States 60521
    17 Novartis Investigative Site Munster Indiana United States 46321
    18 Novartis Investigative Site Des Moines Iowa United States 50314
    19 Novartis Investigative Site Columbia Maryland United States 21044
    20 Novartis Investigative Site Salisbury Maryland United States 21804
    21 Novartis Investigative Site Ypsilanti Michigan United States 48197
    22 Novartis Investigative Site Minneapolis Minnesota United States 55407
    23 Novartis Investigative Site Jackson Mississippi United States 39216
    24 Novartis Investigative Site Saint Louis Missouri United States 63136
    25 Novartis Investigative Site Bridgewater New Jersey United States 08807
    26 Novartis Investigative Site Albany New York United States 12211
    27 Novartis Investigative Site Cooperstown New York United States 13326
    28 Novartis Investigative Site Manhasset New York United States 11030
    29 Novartis Investigative Site Rosedale New York United States 11422
    30 Novartis Investigative Site Cary North Carolina United States 27511
    31 Novartis Investigative Site Lenoir North Carolina United States 28645
    32 Novartis Investigative Site Winston-Salem North Carolina United States 27157
    33 Novartis Investigative Site Canton Ohio United States 44710
    34 Novartis Investigative Site Bend Oregon United States 97701
    35 Novartis Investigative Site Hillsboro Oregon United States 97123
    36 Novartis Investigative Site Rapid City South Dakota United States 57701
    37 Novartis Investigative Site Dallas Texas United States 75226
    38 Novartis Investigative Site Houston Texas United States 77070
    39 Novartis Investigative Site Houston Texas United States 77094
    40 Novartis Investigative Site McKinney Texas United States 75071
    41 Novartis Investigative Site Norfolk Virginia United States 23504
    42 Novartis Investigative Site Winchester Virginia United States 22601
    43 Novartis Investigative Site Tacoma Washington United States 98405

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04873934
    Other Study ID Numbers:
    • CKJX839A1US01
    First Posted:
    May 5, 2021
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Hyperlipidemia
    Atherosclerotic Cardiovascular Disease
    Hypercholesterolemia
    Lipid lowering therapies
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Jul 18, 2022