Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
NCT05360446 · View on ClinicalTrials.gov ↗
Study Summary
CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclisiran sodium 300 mg
Study Locations (20)
California
- Cardiovascular Res Found — Beverly Hills
- UC San Diego Health — La Jolla
- Stanford Health Care — Stanford
- Lundquist Inst BioMed at Harbor — Torrance
New York
- Icahn School of Med at Mt Sinai — New York
- State Uni of NY at Stony Brook — Stony Brook
- Westchester Medical Center — Valhalla
Alabama
- Heart Center Research Llc — Huntsville
Alaska
- Alaska Heart and Vascular — Anchorage
Connecticut
- Bridgeport Hospital — Bridgeport
District of Columbia
- George Washington Univ Medical Ctr — Washington D.C.
Florida
- Inpatient Research Clinical LLC — Miami Lakes
Illinois
- NorthShore University Health System — Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2022-07-08 |
| Est. Completion | 2026-10-26 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05360446
The ClinicalTrials.gov registry entry for NCT05360446 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 610 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05360446 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, New York, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05360446 about?
NCT05360446 is a clinical study titled "Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events". CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) fro...
What is the current status of trial NCT05360446?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 610 participants. The study started on 2022-07-08. Estimated completion is 2026-10-26.
What conditions does trial NCT05360446 study?
This clinical trial studies the following conditions: Coronary Artery Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05360446?
The interventions under investigation include: Placebo (DRUG), Inclisiran sodium 300 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05360446?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05360446 being conducted?
This trial has 20 study locations across Alabama, Alaska, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.