Phase 3 N=400 Randomized Treatment

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

Acute Coronary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT04873934 ↗

Enrolled (actual)

400

Serious AEs

16.5%

Results posted

Aug 2025

Primary outcome: Primary: Percent Change From Baseline to Day 330 in LDL-C — -45.6; 1.4 Percent change in LDL-C — p=< 0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Inclisiran (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Aug 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline to Day 330 in LDL-C	-45.6; 1.4	< 0.001 sig
PRIMARY Achievement of LDL-C < 70 mg/dL at Day 330	66.7; 28.1	< 0.001 sig
SECONDARY Absolute Change From Baseline in LDL-C	-44.2; -2.2; -34.6; -3.8; -41.2; -3.5	< 0.001 sig
SECONDARY Average Percent Change From Baseline in LDL-C Levels	-44.3; 2.4	< 0.001 sig
SECONDARY Average Absolute Change From Baseline in LDL-C Levels	-40.0; -2.7	< 0.001 sig
SECONDARY Achieving ≥50% Reduction From Baseline in LDL-C	45.3; 6.5	< 0.001 sig
SECONDARY Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL	75.8; 40.4; 54.2; 13.6	< 0.001 sig
SECONDARY Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330	-35.5; 2.0; 5.7; 12.1; -35.2; 2.5	< 0.001 sig
SECONDARY Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330	-31.0; -2.6; -0.4; 1.8; -41.4; -1.3	< 0.001 sig
SECONDARY Absolute Change in Lp[a] From Baseline to Day 330	-19.3; -5.3	0.005 sig
SECONDARY Intensity of Lipid Lowering Therapy	9.8; 4.6; 89.1; 92.5; 1.1; 2.9	0.031 sig
SECONDARY Proportion of Days Covered	0.926; 0.965	0.043 sig
SECONDARY Discontinuation of Statin Therapy	14.5; 18.0	0.346

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.

Eligibility 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 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 participants 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04873934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.