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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: Active Phase 3 study of Coronary Artery Disease, sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluating inclisiran compared to placebo both on top of maximally tolerated statin therapy in reducing total coronary atheroma volume assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease (NOCAD) without 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 |
What the registry record for NCT05360446 still lists
NCT05360446 is an interventional study that assigns participants to a tested intervention. The registered 610 participants enrollment target is mid-sized for trials with a published cap, below the 1,284-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (52% lower).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
Similar trials for Coronary Artery 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 NCT05360446's enrollment target sits among peer trials
610 66th of 219 higher than 154 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery 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.
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