Clinical Trial

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

Study acronym: ORION-4
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2018-10-10; most recent amendment 2026-04-30.
Status change: Recruiting → Active, Not Recruiting 2023-10-31
Status change: Not Yet Recruiting → Recruiting 2019-03-21
Trial Details
NCT Number NCT03705234
Lead Sponsor University of Oxford
Collaborators: The TIMI Study Group, Novartis Pharmaceuticals
Conditions Atherosclerotic Cardiovascular Disease
Enrollment 16,124 participants
Start Date 2018-10-30
Primary Completion 2026-10 (estimated)
Study Completion 2049-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-01