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NCT05360446 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Coronary Artery Disease, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 610
- Enrollment target
- 20
- Study locations
NCT05360446 is a Phase 3 study of Coronary Artery Disease that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 610 participants, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT05360446, a Phase 3 study of Coronary Artery Disease, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 610 participants
- Enrollment target
- 20
- Study locations
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?
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, categorized as Phase 3. The registered enrollment target is 610 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (52% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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.
NCT05360446 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, New York, Alabama.
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.
What interventions are being tested in trial NCT05360446?
The interventions under investigation include: Placebo (DRUG), Inclisiran sodium 300 mg (DRUG).
Who is sponsoring clinical trial NCT05360446?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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.