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

NCT07736313 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: PCSK9 inhibitors in ACS
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by Fibroscan, Any change in Liver structure at 6 Months

  2 year

Study Arms (2)

Case group

ACTIVE COMPARATOR

will receive PCSK9 inhibitors with rosuvastatin 20mg

Drug: PCSK9 inhibitor plus rosuvastatin 20 mg tab

control group

PLACEBO COMPARATOR

Drug: Rosuvastatin 20 Mg Oral Tablet

Interventions

PCSK9 inhibitor plus rosuvastatin 20 mg tab DRUG

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

Case group

Rosuvastatin 20 Mg Oral Tablet DRUG

only statin given to the patient

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients \> 18 y.o
• Patients who have chronic liver disease other than MASLD
• Patients having liver neoplasm
• Patient refused

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 32863243 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium; Tablets

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Christina Saeed Boules, resident doctor

CONTACT

+201559724062; Christinasaeed3@gmail.com

Tarek AbdelHamid Naguib, Professor

CONTACT

+201099975128; Tarek.a.n.ahmed@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07