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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
610
Subcutaneously administered on Days 1, Month 3 (Day 90), and every 6 months thereafter.
Subcutaneously administered on Day 1, Month 3 (Day 90), and every 6 months thereafter.
Heart Center Research Llc
Huntsville, Alabama, United States
Alaska Heart and Vascular
Anchorage, Alaska, United States
Cardiovascular Res Found
Beverly Hills, California, United States
UC San Diego Health
La Jolla, California, United States
Stanford Health Care
Stanford, California, United States
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.
Time frame: From baseline to month 24
Percentage change in LDL-C
Full fasting lipid panel will be collected throughout the study beginning at baseline.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to month 24
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Lundquist Inst BioMed at Harbor
Torrance, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
George Washington Univ Medical Ctr
Washington D.C., District of Columbia, United States
Inpatient Research Clinical LLC
Miami Lakes, Florida, United States
NorthShore University Health System
Evanston, Illinois, United States
...and 79 more locations