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NCT03705234 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Atherosclerotic Cardiovascular Disease, sponsored by University of Oxford.

Active
Registry status
Phase 3
Development phase
16,124
Enrollment target
2
Study locations

NCT03705234 is a Phase 3 study of Atherosclerotic Cardiovascular Disease that is active but no longer recruiting, run by University of Oxford. The registered enrollment target is 16,124 participants, above the 6,800-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (137% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT03705234, a Phase 3 study of Atherosclerotic Cardiovascular Disease, is active but no longer recruiting, sponsored by University of Oxford.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
16,124 participants
Enrollment target
2
Study locations

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Inclisiran

Study Locations (2)

Massachusetts

  • TIMI Study Group - Boston

Oxfordshire

  • CTSU, University of Oxford - Oxford

Trial Details

FieldValue
Enrollment Target 16,124 participants
Start Date 2018-10-30
Est. Completion 2049-12
Phase Phase 3

Sponsor

University of Oxford

5 total trials

What the Registry Record Tells You About NCT03705234

The ClinicalTrials.gov registry entry for NCT03705234 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 16,124 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 6,800-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (137% higher). The listed sponsor is University of Oxford, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03705234 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Oxfordshire.

Frequently Asked Questions

What is clinical trial NCT03705234 about?

NCT03705234 is a clinical study titled "A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease". 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 ...

What is the current status of trial NCT03705234?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 16,124 participants. The study started on 2018-10-30. Estimated completion is 2049-12.

What conditions does trial NCT03705234 study?

This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease.

What interventions are being tested in trial NCT03705234?

The interventions under investigation include: Placebo (DRUG), Inclisiran (DRUG).

Who is sponsoring clinical trial NCT03705234?

This trial is sponsored by University of Oxford, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03705234 being conducted?

This trial has 2 study locations across Massachusetts, Oxfordshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.