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 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: CKJX839A1SA03
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Acute Coronary Syndrome

Keywords

Hyperlipidemia; Recent acute coronary syndrome; Lipid lowering therapies

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL-C from baseline at Day 60

  Difference in percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) between inclisiran + SOC group and SOC alone group

  Baseline and Day 60

Secondary Outcomes (16)

• Absolute change from baseline in LDL-C levels

  Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

• Average percent change from baseline in LDL-C levels

  Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

• Average absolute change from baseline in LDL-C levels

  Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

• Proportion of participants achieving LDL-C levels <1.4 mmol/L

  Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

• Proportion of participants achieving LDL-C levels <1.8 mmol/L

  Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

Study Arms (3)

Phase 1: inclisiran + SOC

EXPERIMENTAL

Inclisiran sodium 300 mg administered on Day 1 and Day 90 on top of standard of care (SOC)

Drug: inclisiran; Drug: SOC

Phase 1: SOC

ACTIVE COMPARATOR

standard of care (SOC) alone

Drug: SOC

Phase 2: inclisiran + SOC

EXPERIMENTAL

Inclisiran sodium 300 mg administered on Day 90 and Day 180 for switched group (SOC alone group from first phase) on top of SOC

Drug: inclisiran; Drug: SOC

Interventions

inclisiran DRUG

Inclisiran sodium 300 mg

Also known as: KJX839

Phase 1: inclisiran + SOC; Phase 2: inclisiran + SOC

SOC DRUG

consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe)

Phase 1: SOC; Phase 1: inclisiran + SOC; Phase 2: inclisiran + SOC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Fasting triglycerides \<4.52 mmol/L (\<400 mg/dL) at screening.
• Estimated glomerular filtration rate (eGFR) \>30 mL/min at screening.
• Participants must be willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.

You may not qualify if:

• 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.
• Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization (assessed at screening visit) despite antihypertensive therapy.
• Homozygous familial hypercholesterolemia (HoFH) defined as LDL-C ≥ 12 mmol/L.
• Statin intolerant patients defined as documented side effects on 2 different statins, including one at the lowest standard dose.
• Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
• History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization.
• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
• Breastfeeding women.
• Treatment with other investigational products or devices within 30 days or five half-lives of the screening visit, whichever is longer.
• History of hypersensitivity to any of the study treatments or its excipients, or to drugs of similar chemical classes (statins, ezetimibe, and inclisiran).
• Planned use of other investigational products or devices during the course of the study.
• Any condition that, according to the investigator, could interfere with the conduct of the study, such as but not limited to:

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Acute Coronary Syndrome; Hyperlipidemias

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share