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

Study acronym: ORION-4
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion date: Jul 2026 to Oct 2026v10
  3. Re-verified, no change to tracked fieldsv9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 15000 to confirmed 16124
    • Site details revised at 2 of 2 sites
    v8
  5. Eligibility criteria expanded, about 12 words
    • Study description expanded, about 9 words
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 1 to 2v6
  2. Primary endpoint revised
    • Secondary endpoints: 2 to 3
    v5
  3. Primary completion date: Dec 2024 to Jul 2026
    • Collaborators revised (2)
    v4
  4. Study description revised
    • Eligibility criteria expanded, about 4 words
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Primary endpoint revised
    • Start date changed from estimate of Oct 2018 to Oct 30, 2018
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints revised (2)
    • Site details revised
    • Study title shortened, about 3 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03705234
Lead Sponsor University of Oxford
Collaborators: The TIMI Study Group, Novartis Pharmaceuticals
Conditions
(from sponsor)		 Atherosclerotic Cardiovascular Disease
Related terms Atherosclerosis
Enrollment 16,124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov