Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

Conditions

• Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Inclisiran sodium 300 mg — DRUG
  Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
• Placebo — DRUG
  Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit

Study Details

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

Key Dates

Start date

Nov 23, 2021

Status verified

Jun 2026

Primary completion

Oct 13, 2027

Completion

Oct 13, 2027

Study Design

Enrollment

17,004 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Inclisiran sodium
  Subcutaneous injection
• Placebo Comparator: Placebo
  Subcutaneous injection

Primary Outcome Measure

Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events) [ Time Frame: From randomization to total follow-up time (up to 72 months) ]

Locations (272)

Find similar trials in Birmingham, AL

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