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NCT05030428 · ClinicalTrials.gov registry record · Phase 3
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
A Phase 3 study of Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 17,004
- Enrollment target
- 20
- Study locations
NCT05030428: Active Phase 3 study of Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
NCT05030428 is a Phase 3 study of Atherosclerotic Cardiovascular Disease that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 17,004 participants, above the 6,758-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (152% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05030428, a Phase 3 study of Atherosclerotic Cardiovascular Disease, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 17,004 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
Primary Outcome
3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran sodium 300 mg
Study Locations (20)
California
- Central Cardiology Medical Center - Bakersfield
- Alliance Clinical - Canoga Park
- Inland Psychiatric Medical Group - Chino
- John Muir Physician Network Clinical Research Center - Concord
- Triallogix - Fullerton
- Diabetes Lipid Management Center - Huntington Beach
- University of Calif Irvine Med Cntr - Irvine
- UC San Diego Health - La Jolla
Arizona
- Mercy Gilbert Medical Center - Gilbert
- Cardiovascular Associates of Mesa - Mesa
- Elite Clinical Studies - Phoenix
- HonorHealth Heart Group Deer Valley - Scottsdale
- Clinical Research Inst of Arizona - Sun City West
- Pima Heart And Vascular Clin Rch - Tucson
Alabama
- UAB St Vincents - Birmingham
- Eastern Shore Research Institute - Fairhope
- G and L Research LLC - Foley
Arkansas
- ARcare Center for Clinical Research - Little Rock
- Arkansas Clinical Research - Little Rock
Alaska
- Alaska Heart and Vascular - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17,004 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2027-10-13 |
| Phase | Phase 3 |
What the registry record for NCT05030428 still lists
NCT05030428 is an interventional study that assigns participants to a tested intervention. Its 17,004 participants enrollment target places it among the larger protocols in the corpus, above the 6,758-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (152% 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.
NCT05030428 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05030428 about?
NCT05030428 is a clinical study titled "Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease". Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
What is the current status of trial NCT05030428?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 17,004 participants. The study started on 2021-11-23. Estimated completion is 2027-10-13.
What conditions does trial NCT05030428 study?
This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease.
What interventions are being tested in trial NCT05030428?
The interventions under investigation include: Placebo (DRUG), Inclisiran sodium 300 mg (DRUG).
Who is sponsoring clinical trial NCT05030428?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05030428 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. 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 NCT05030428's enrollment target sits among peer trials
17,004 3rd of 21 higher than 19 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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