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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: Active Phase 3 study of Atherosclerotic Cardiovascular Disease, sponsored by University of Oxford.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as time to first occurrence - during the scheduled treatment period - of: * Coronary heart disease (CHD) death; * Myocardial infarction; * Fatal or non-fatal ischemic stroke; or * Urgent coronary revascularization procedure.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran
Study Locations (2)
Massachusetts
- TIMI Study Group - Boston
Oxfordshire
- CTSU, University of Oxford - Oxford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16,124 participants |
| Start Date | 2018-10-30 |
| Est. Completion | 2049-12 |
| Phase | Phase 3 |
What the registry record for NCT03705234 still lists
NCT03705234 is an interventional study that assigns participants to a tested intervention. Its 16,124 participants enrollment target places it among the larger protocols in the corpus, above the 6,800-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (137% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Atherosclerotic Cardiovascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03705234's enrollment target sits among peer trials
16,124 4th of 21 higher than 18 of 21 other Atherosclerotic Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atherosclerotic Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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The Prevent Coronary Artery Disease Trial
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Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
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-
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
ACTIVE NOT RECRUITING · Phase 3
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