Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07102628
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Acute Coronary Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    The participants will receive placebo subcutaneous at randomization (Day 1, Baseline visit) and Day 90
  • Inclisiran — DRUG
    The participants will receive Inclisiran sodium 300 mg subcutaneous at randomization (Day 1, Baseline visit) and Day 90

Study Details

The purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), when this treatment is started early after hospital admission. To do this, researchers will test the effects of inclisiran compared to placebo, when given with standard treatment.

Key Dates

Start date
Oct 3, 2025
Status verified
May 2026
Primary completion
Feb 11, 2027
Completion
Feb 11, 2027

Study Design

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

Arms

  • Experimental: Inclisiran sodium 300 mg s.c. + Standard treatment
    * Inclisiran sodium 300 mg subcutaneous (s.c.) on top of HIS (+/- LLT) or non-statin LLT in statin intolerant participants * KJX839 284 mg / 1.5 mL (Dose: 300 mg) * Pharmaceutical Dosage Form: solution for subcutaneous injection
  • Placebo Comparator: Matching placebo + Standard treatment
    * Matching placebo on top of HIS (+/- LLT) or non-statin LLT in statin intolerant participants * KJX839 Placebo / 1.5 mL (Dose: 0 mg) * Pharmaceutical Dosage Form: solution for subcutaneous injection

Primary Outcome Measure

Percent change in LDL-C [ Time Frame: From baseline to Day 150 ]

Central Contacts

  • Novartis Pharmaceuticals
    +41613241111
    [email protected]
  • Novartis Pharmaceuticals
    +81337978748

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