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Trial record 1 of 1 for:    CKJX839A1US01
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Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome (V-INCEPTION)

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ClinicalTrials.gov Identifier: NCT04873934
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : November 21, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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
Acute Coronary Syndrome Drug: Inclisiran 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 24, 2021
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024

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Arms and Interventions
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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 Name: KJX839
No Intervention: Usual Care
Usual Care Alone


Outcome Measures
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Primary Outcome Measures :
  1. Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline and Day 330 ]
    Inclisiran compared to usual care on discontinuation of statin therapy from baseline to Day 330


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873934


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04873934    
Other Study ID Numbers: CKJX839A1US01
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: November 21, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hyperlipidemia
Atherosclerotic Cardiovascular Disease
Hypercholesterolemia
Lipid lowering therapies
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases