Active — Not RecruitingPhase 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

United States610 participantsStarted 2022-07-08

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Participant with CT-adapted Leaman score \>5. and a diameter stenosis \<50% or
✓. Participants with a CT-adapted Leaman score \>5, a diameter stenosis ≥50% but with FFRCT ≥0.76.

What they're measuring

Percentage change in total coronary atheroma volume

Timeframe: From baseline to month 24

Trial details

NCT IDNCT05360446

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-26

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