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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) 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.
Study details:
The purpose of this study is to evaluate the efficacy of inclisiran compared to placebo on top of maximally tolerated dose of statin therapy in reducing total coronary atheroma volume assessed by CCTA in participants with a diagnosis of Non-Obstructive Coronary Artery Disease (NOCAD) without previous cardiovascular events, who have an LDL-C ≥55 mg/dL (1. 4 mmol//L), no significant pressure drop in Fractional Flow Reserve Computed Tomography (FFRCT) and a CT-adapted Leaman score \>5 despite the use of maximally tolerated statin therapy(and if applicable, another LLT on top of statin therapy for at least 30 days in up to 20% of randomized participants).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-07-08
Primary completion: 2027-01-25
Study completion finish: 2027-01-25
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05360446
Intervention or treatment
DRUG: Inclisiran sodium 300 mg
DRUG: Placebo
Conditions
- • Coronary Artery Disease
Find a site
Closest Location:
Novartis Investigative Site
Research sites nearby
Select from list below to view details:
Novartis Investigative Site
Auchenflower, Queensland, Australia
Novartis Investigative Site
Chemside, Queensland, Australia
Novartis Investigative Site
Milton, Queensland, Australia
Novartis Investigative Site
Leabrook, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
EXPERIMENTAL: Inclisiran sodium
| DRUG: Inclisiran sodium 300 mg
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Percentage change in total coronary atheroma volume | 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. | From baseline to month 24 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Percentage change in LDL-C | Full fasting lipid panel will be collected throughout the study beginning at baseline. | From baseline to month 24 |
Percentage change in low attenuation plaque volume evaluated by CCTA | Evaluating inclisiran compared to placebo in percentage change in low attenuation plaque volume evaluated by CCTA. | From baseline to month 24 |
Percentage of participants with progression, regression, or no change of total plaque atheroma volume | Evaluating inclisiran compared to placebo in percentage of participants experiencing progression, regression, or no change of total atheroma volume. | From baseline to month 24 |
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