Inclisiran sodium for Coronary Artery Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, Hasselt, Belgium
Coronary Artery Disease+3 More
Inclisiran sodium 300 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Coronary Artery Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From baseline to month 24

Month 24
Percentage change in LDL-C
Percentage change in low attenuation plaque volume evaluated by CCTA
Percentage change in total coronary atheroma volume
Percentage of participants with progression, regression, or no change of total plaque atheroma volume

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Inclisiran sodium
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

600 Total Participants · 2 Treatment Groups

Primary Treatment: Inclisiran sodium · Has Placebo Group · Phase 3

Inclisiran sodium
Drug
Experimental Group · 1 Intervention: Inclisiran sodium 300 mg · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to month 24
Closest Location: Novartis Investigative Site · Canton, OH
Photo of novartis investigative site  1Photo of novartis investigative site  2Photo of novartis investigative site  3
2013First Recorded Clinical Trial
6 TrialsResearching Coronary Artery Disease
1407 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have coronary artery plaque with visual diameter stenosis <50%.
You are at least 18 years old or at least 80 years old.
Presence of coronary artery plaque with visual diameter stenosis <50% or Coronary artery plaque with visual artery stenosis >50% but Fractional Flow Reserve (FFR) >0.
A standard of care CCTA may serve as the study baseline CCTA scan if it is performed within 3 months prior to the participant's Screening Visit and meets the inclusion criteria of FFRct >0.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.