A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
University of Oxford
Study ID
NCT03705234
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Atherosclerotic Cardiovascular Disease

Eligibility Criteria

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

Interventions

  • Inclisiran — DRUG
    Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
  • Placebo — DRUG
    Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

Study Details

ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU\_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.

Key Dates

Start date
Oct 30, 2018
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2049

Study Design

Enrollment
16,124 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Inclisiran
    Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection at randomization, 3 months and then every 6 months.
  • Placebo Comparator: Placebo
    Placebo will be administered as SC injections of saline solution at randomization, 3 months and then every 6 months.

Primary Outcome Measure

Number of participants with a major adverse cardiovascular event (MACE) [ Time Frame: Median follow-up of 5-years ]

Locations (1)

FacilityCityStateZIPSite coordinators
TIMI Study GroupBostonMassachusetts02115-

Find similar trials in Boston, MA

By research site
TIMI Study Group· Boston, MA

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