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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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).

Eligibility criteria

Qualifiers

Males and females ≥18 years of age.

Recent ACS (in-patient/out-patient) within 7 days of index admission, as per 2023 ESC guidelines for the management of acute coronary syndrome

Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) or non-HDL ≥100 mg/dL at screening for participants who were receiving SOC [including lipid lowering therapy and/or ezetimibe] prior enrollment.

Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL) or non-HDL ≥124 mg/dL at screening for participants who were SOC treatment naïve prior enrollment.

Disqualifiers

Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study.

An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.

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.

Trial design

Treatments tested in this trial

  • inclisiran
  • SOC

Treatment groups

300 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators