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NCT05739383 · ClinicalTrials.gov registry record · Phase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
A Phase 3 study of Primary Prevention of Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 14,078
- Enrollment target
- 20
- Study locations
NCT05739383: Active Phase 3 study of Primary Prevention of Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
NCT05739383 is a Phase 3 study of Primary Prevention of Atherosclerotic Cardiovascular Disease that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 14,078 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1726% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05739383, a Phase 3 study of Primary Prevention of Atherosclerotic Cardiovascular Disease, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 14,078 participants
- Enrollment target
- 20
- Study locations
Study Summary
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
Primary Outcome
4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization.
Conditions Studied
Interventions
- DRUG Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- DRUG Placebo in 1.5ml
Study Locations (20)
Alabama
- Central Alabama Research - Birmingham
- UAB St Vincents - Birmingham
- Eastern Shore Research Institute - Fairhope
- G and L Research LLC - Foley
- Longwood Research - Huntsville
- CB Flock Corporation - Mobile
- Mobile Heart Specialists - Mobile
- The Center for Clinical Trials - Saraland
Arizona
- Synexus - Glendale
- Lenzmeier Family Practice - Glendale
- Avacare Center for Dermatology - Phoenix
- Clinical Research Inst of Arizona - Sun City West
- Clinical Research Advantage Fiel Family and Sports Med, PC - Tempe
- Synexus Clinical Research US Inc - Tucson
California
- Cardiovascular Res Found - Beverly Hills
- National Heart Institute - Beverly Hills
- Alliance Clinical - Canoga Park
- Inland Psychiatric Medical Group - Chino
- Valley Clinical Trials Inc - Covina
- Keck Medical Center USC - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,078 participants |
| Start Date | 2023-03-09 |
| Est. Completion | 2029-04-16 |
| Phase | Phase 3 |
What the registry record for NCT05739383 still lists
NCT05739383 is an interventional study that assigns participants to a tested intervention. Its 14,078 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1726% higher).
The record links to 1 condition, with Primary Prevention of Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL is the first listed.
NCT05739383 names 20 study sites across 3 states, led by Alabama, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05739383 about?
NCT05739383 is a clinical study titled "A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.". CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic card...
What is the current status of trial NCT05739383?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 14,078 participants. The study started on 2023-03-09. Estimated completion is 2029-04-16.
What conditions does trial NCT05739383 study?
This clinical trial studies the following conditions: Primary Prevention of Atherosclerotic Cardiovascular Disease.
What interventions are being tested in trial NCT05739383?
The interventions under investigation include: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL (DRUG), Placebo in 1.5ml (DRUG).
Who is sponsoring clinical trial NCT05739383?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05739383 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05739383's enrollment target sits among peer trials
14,078 16th of 2000 higher than 1,985 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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