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

Completed · Phase 3

Conditions studied: Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT04873934

Run by

Novartis Pharmaceuticals

People needed

400

Starts

2021-06-24

Expected to finish

2024-08-07

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify 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.

Where it is running

• Central Cardiology Medical Center — Bakersfield, California, United States
• The Heart Group Cardiovascular Associates Inc — Fresno, California, United States
• Mission Heritage Medical Group — Mission Viejo, California, United States
• Northbay Clinical Research LLC — Santa Rosa, California, United States
• Clinnova Research Solutions — Torrance, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Interv Cardiology Med Grp — West Hills, California, United States
• Aurora Denver Cardiology Associates — Aurora, Colorado, United States
• Colorado Springs Cardiology — Colorado Springs, Colorado, United States
• Colorado Heart and Vascular — Lakewood, Colorado, United States
• Cardiology Ass of Fairfield County — Stamford, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• George Washington Univ Medical Ctr — Washington D.C., District of Columbia, United States
• Nova Clinical Research LLC — Bradenton, Florida, United States
• Teradan Clinical trials LLC — Brandon, Florida, United States
• Clearwater Cardiovascular and Interventional Consultants — Clearwater, Florida, United States
• Cardiology Research Associates — Daytona Beach, Florida, United States
• Holy Cross Hospital Inc — Fort Lauderdale, Florida, United States
• Baptist Health Research Institute — Jacksonville, Florida, United States
• Reliant Medical Research — Miami, Florida, United States
• Inpatient Research Clinical LLC — Miami Lakes, Florida, United States
• Innovation Medical Group LLC — Palmetto Bay, Florida, United States
• Cardiology Consultants — Pensacola, Florida, United States
• Theia Clinical Research Ctrs LLC — Tampa, Florida, United States
• Northeast Arkansas Baptist Clinic — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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