Inclisiran sodium for Coronary Artery Disease
Phase-Based Progress Estimates
Effectiveness
Safety
Novartis Investigative Site, Hasselt, Belgium
Coronary Artery Disease+3 More
Inclisiran sodium 300 mg - DrugEligibility
18+
All Sexes
What conditions do you have?
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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
This is further along than 85% of similar trials
Other trials for Coronary Artery Disease
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
This is further along than 85% of similar trials
Other trials for Coronary Artery Disease
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: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to month 24
Closest Location: Novartis Investigative Site · Canton, OH
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 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.
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