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

Novartis Pharmaceuticals400 enrolled

Overview

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.

This was a randomized, parallel-group, open-label, multicenter, 1-year (30-day Screening Period and 330-day Treatment Period) study comparing an LDL-C management strategy including inclisiran + usual care to usual care alone. Approximately 384 participants were planned to be randomized 1:1 to aggressive LDL-C management with inclisiran + usual care (intervention arm) (3 inclisiran doses) or usual care (control arm). Usual care could have included addition of ezetimibe, bempedoic acid, PCSK9-inhibiting monoclonal antibodies, and/or commercially available inclisiran

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Acute Coronary Syndrome

Interventions

InclisiranDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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 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.

Locations (88)

Outcomes

Primary Outcomes

Percent Change From Baseline to Day 330 in LDL-C

Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330

Time frame: Baseline and Day 330

Achievement of LDL-C < 70 mg/dL at Day 330

Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) \< 70 mg/dL at Day 330

Time frame: Day 330

Secondary Outcomes

Absolute Change From Baseline in LDL-C

Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) by visit

Time frame: Baseline, Day 90, Day 270 and Day 330

Average Percent Change From Baseline in LDL-C Levels

Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit

Time frame: Baseline, from Day 90 to Day 330

Average Absolute Change From Baseline in LDL-C Levels

Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit

Time frame: Baseline, From Day 90 to Day 330

Achieving ≥50% Reduction From Baseline in LDL-C

Percentage of participants achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Day 330

Time frame: Baseline, Day 330

Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL

Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) \<100 mg/dL (among the subset of participants with baseline LDL-C \>= 100 mg/dL) and LDL-C \< 55 mg/dL at Day 330

Data from ClinicalTrials.gov

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