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ACTIVE NOT RECRUITING
NCT03705234
PHASE3

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

Sponsor: University of Oxford

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.

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

Interventions

DRUG

Inclisiran

Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

DRUG

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