Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Torrance, California and other locations
Dates
study started
completion around

Description

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,

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)

Details

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,

Keywords

Acute Coronary Syndrome, Hyperlipidemia, Atherosclerotic Cardiovascular Disease, Hypercholesterolemia, Lipid lowering therapies, Syndrome, Inclisiran

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • Harbor-UCLA Medical Center The Lindquist Institute
    Torrance California 90502 United States
  • Clinnova Research Solutions
    Torrance California 90277 United States
  • Interv Cardiology Med Grp
    West Hills California 91307 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT04873934
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 400 people participating
Last Updated