A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Conditions

• Primary Prevention of Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL — DRUG
  Subcutaneous injection in pre-filled syringe.
• Placebo in 1.5ml — DRUG
  Matching placebo in 1.5ml solution for injection

Study Details

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

Key Dates

Start date

Mar 9, 2023

Status verified

Jun 2026

Primary completion

Apr 16, 2029

Completion

Apr 16, 2029

Study Design

Enrollment

14,012 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Inclisiran sodium 300mg
  Inclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe. Randomized in a 1:1 ratio with matching placebo
• Placebo Comparator: Placebo
  Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.

Primary Outcome Measure

Time to the first occurrence of 4P-MACE [ Time Frame: Time to the first occurrence of 4P-MACE (up to approximately 75 months) ]

Locations (243)

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