Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors With Statin for ACS Patients

Does PCSK9 Inhibitor on Top of High Intensity Statin Impact Liver Steatosis Assessed by FibroScan in Diabetic Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes?

Cardiovascular diseases (CVDs) remain the leading cause of death globally, with a dominant contribution from atherosclerotic CVD (ASCVD).

• Percutaneous coronary intervention (PCI) is a key method for revascularization in ASCVD patients, improving their prognosis. With the continuous advancement of PCI in recent years, its indications have become increasingly diverse. However, patients still face a pronounced residual risk post-PCI. Research indicates that plaque vulnerability and other risk factors contribute to a 15%-20% rate of major adverse cardiovascular events (MACE) within one year following PCI.
• The pathological mechanism of atherosclerosis is closely tied to the abnormal deposition of low-density lipoprotein cholesterol (LDL-C) beneath the vascular endothelium. This lipid particle can provoke a chronic inflammatory response in the vessel wall, eventually causing plaque formation. Moreover, the marked elevation of LDL-C levels is highly connected to the occurrence and progression of ASCVD.
• Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, with a prevalence of approximately 25% (range 14%-32%).
• It is regarded as the hepatic manifestation of metabolic syndrome (MetS) and is strongly associated with obesity and diabetes mellitus (DM).
• Cardiovascular (CV) disease is one of the leading causes of death in patients with MASLD
• Statins are the cornerstone of lipid-lowering therapy, noticeably diminishing LDL-C levels by blockading HMG-CoA reductase. For patients following PCI, several guidelines suggest high-intensity statin therapy to reach a target LDL-C level of ≤1.4 mmol/L and a ≥50% decline from baseline.
• However, even with intensive statin therapy, many post-PCI patients still exhibit LDL-C levels above the target limits.
• Inhibitors of proprotein convertase subtilisin/kexin type 9(PCSK9) notably decrease plasma LDL-C levels by preventing the binding of PCSK9 protein to LDL-C receptors (LDLR) on hepatocyte surfaces, thereby decreasing LDLR degradation. In 2019, guidelines for managing dyslipidemia from the ESC/EAS emphasize that PCSK9 inhibitors should be added for patients with insufficiently controlled LDL-C levels to achieve the target levels.
• Combining PCSK9 inhibitors with statins has been proven to lead to a 60%-70% reduction in LDL-C levels.
• Recently, a novel non-invasive parameter to assess steatosis has been developed using the Fibroscan® which is a vibration-controlled transient elastography (VCTE™) device used to assess liver elasticity which is related to liver fibrosis. This novel physical parameter, based on the properties of ultrasonic signals acquired by the Fibroscan®, is called the controlled attenuation parameter (CAP). It uses the postulate that fat affects ultrasound propagation, and is a measure of ultrasound attenuation at the central frequency of the Fibroscan
• In this study, the investigators will demonstrate overall effect of PCSK9 inhibitors in combination with statins on MASLD and lipid levels for post-PCI patients, and to compare the degree of risk reduction with statin monotherapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: Drug: PCSK9 inhibitor plus rosuvastatin 20 mg tab; Drug: Rosuvastatin 20 Mg Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Christina Saeed Boules, resident doctor; Phone Number: +201559724062; Email: Christinasaeed3@gmail.com
• Study Contact Backup: Name: Tarek AbdelHamid Naguib, Professor; Phone Number: +201099975128; Email: Tarek.a.n.ahmed@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18y.o
2. Any patient presented with acute coronary syndromes (Myocardial infarction (MI), non-ST elevation Myocardial infarction (NSTEMI), unstable angina) underwent coronary angiography within admission.
3. Patients must be diabetic.
4. Statin naïve patients at the time of enrollment.

Exclusion Criteria:

1. patients > 18 y.o
2. Patients who have chronic liver disease other than MASLD
3. Patients having liver neoplasm
4. Patient refused

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	Drug: Rosuvastatin 20 Mg Oral Tablet; only statin given to the patient
Active Comparator: Case group; will receive PCSK9 inhibitors with rosuvastatin 20mg	Drug: PCSK9 inhibitor plus rosuvastatin 20 mg tab; Group of ACS patients & diagnosed with DM will have PCSK9 inhibitor with rosuvastatin 20 mg tab & another group will have rosuvastatin 20 mg tab only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment-Related Adverse Events as Assessed by Fibroscan, Any change in Liver structure at 6 Months	2 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Tamez H, Secemsky EA, Valsdottir LR, Moussa ID, Song Y, Simonton CA, Gibson CM, Popma JJ, Yeh RW. Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries. EuroIntervention. 2021 Aug 6;17(5):e380-e387. doi: 10.4244/EIJ-D-19-01031.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Dosage Forms; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Rosuvastatin Calcium; Tablets
• Other Study ID Numbers: PCSK9 inhibitors in ACS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No