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)
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.
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,
Acute Coronary Syndrome
Jun 24, 2021
Mar 20, 2024
18 Years and older (Adult, Older Adult)
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
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
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.