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 (V-PLAQUE)

You may be able to join if

• Written informed consent must be obtained before any assessment is performed.
• Male or female ≥ 18 to ≤ 80 years of age at signing of informed consent.
• Fasting LDL-C local lab value at the Screening Visit of either i) ≥100 mg/dL (2.6 mmol/L) if on statin therapy but not on a maximally tolerated statin therapy; ii) ≥150 mg/dL (3.9 mmol/L) if statin naive and without documented statin intolerance; or iii) ≥55 mg/dL (1.4 mmol/L) if on a stable (≥4 weeks) dose of maximally tolerated statin therapy or if statin intolerant. Local laboratory values should be calculated using the Friedewald formula for consistency across study sites if the Screening visit occurs prior to the Baseline CCTA Visit. If the Screening and Baseline Visits occur on the same day, then the LDL-C value will be assessed on the central laboratory sample. If the center can only perform the direct LDL-C test, then the local lab should also obtain the total cholesterol, HDL-C, and triglycerides results so that the LDL-C can be calculated using the Friedewald estimation..
• Fasting LDL-C local lab value ≥55 mg/dL (1.4 mmol/L) at the assessment performed during the Statin Optimization Period 3 Visit for participants going through the Statin Optimization Period. Local laboratory values should be calculated using the Friedewald formula for consistency across study sites. If the center can only perform the direct LDL-C test, then the local lab should also obtain the total cholesterol, HDL-C, and triglycerides results so that the LDL-C can be calculated using the Friedewald estimation.
• Participants having NOCAD without previous cardiovascular events: NOCAD is defined as: 1) Participants with a CT-adapted Leaman score >5 and a diameter stenosis of <50%. OR 2) Participants with a CT-adapted Leaman score >5, a diameter stenosis ≥50%* but with FFRCT ≥0.76**. Notes: *=In case of left main CAD, diameter stenosis is ≥40%. **=In case of FFRCT between ≥0.76 and 0.80, participant eligibility will be assessed and determined by the Imaging Core Lab based on the location of the lesion, proximality of the lesion, delta FFRCT and diffuseness of coronary artery disease, (Cury et al 2022). FFRCT and CT-adapted Leaman score will be determined by the Imaging Core Lab. 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 as described above and as assessed by the Imaging Core Lab.
• At the Baseline Visit, participants must be on a stable (≥4 weeks), dose of maximally tolerated statin therapy. Participants not on maximally tolerated statin therapy and who do not have documented statin intolerance can be screened but must enter the study via a Statin Optimization Period.