drugset / Trial / NCT07684469

Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia

NCT07684469

Phase 4 Not yet recruiting 300 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome. This pathway includes treatment with inclisiran on top of the standard of care (SOC), which consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe).

Timeline

Start
2026-06-30
Primary completion
2027-02-28
Completion
2028-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Inclisiran Small interfering RNA (siRNA) 300 mg
Background Ezetimibe Unknown