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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07684469
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Coronary Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • inclisiran — DRUG
    Inclisiran sodium 300 mg
  • SOC — DRUG
    consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe)

Study Details

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).

Key Dates

First listed
Jul 6, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: inclisiran + SOC
    Inclisiran sodium 300 mg administered on Day 1 and Day 90 on top of standard of care (SOC)
  • Active Comparator: Phase 1: SOC
    standard of care (SOC) alone
  • Experimental: Phase 2: inclisiran + SOC
    Inclisiran sodium 300 mg administered on Day 90 and Day 180 for switched group (SOC alone group from first phase) on top of SOC

Primary Outcome Measure

Percent change in LDL-C from baseline at Day 60 [ Time Frame: Baseline and Day 60 ]

Central Contacts

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