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A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
Sponsor: University of Oxford
Summary
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.
Official title: HPS-4/TIMI 65/ORION-4: A Double-blind Randomized Placebo-controlled Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Atherosclerotic Cardiovascular Disease
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
16124
Start Date
2018-10-30
Completion Date
2049-12
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
Inclisiran
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Placebo
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Locations (2)
TIMI Study Group
Boston, Massachusetts, United States
CTSU, University of Oxford
Oxford, Oxfordshire, United Kingdom