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

Exclusion Criteria

• •Previous cardiovascular events history including myocardial infarction (MI), or prior coronary revascularization \[percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)\].
• •Planned revascularization (PCI) or (CABG).
• •Previous cerebrovascular events including:
• •* Prior ischemic stroke thought not to be caused by atrial fibrillation, valvular heart disease or mural thrombus.
• •* History of prior percutaneous or surgical carotid artery revascularization.
• •History of Peripheral Artery Disease (PAD):
• •* Prior documentation of a resting ankle-brachial index \<0.85.
• •* History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery.
• •* Prior non-traumatic amputation of a lower extremity due to peripheral artery disease.
• •Cardiac disorders, including any of the following:
• •* Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation) within 3 months prior to randomization that is not controlled by medication or via ablation at the time of the Screening Visit.
• •* Complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) prior to randomization.
• •Contraindication for CCTA (e.g., allergic reactions to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA Visit as assessed by the Imaging Core Lab.
• •Pacemaker or implantable cardioverter-defibrillator (ICD) in situ.
• •Systolic Left Ventricle Ejection Fraction \<30% at the Screening Visit.
• •Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy.
• •Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit.
• •Renal insufficiency (eGFR \<30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit and at the Statin Optimization 3 Visit.
• •Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit.
• •Local creatine kinase (CK) values of either, unless a more stringent threshold is mandated by a local regulatory authority
• •Local CK values ≥5x ULN at the Statin Optimization 3 Visit unless a more stringent threshold is mandated by a local regulatory authority
• •Participant with myopathy at the Statin Optimization 3 Visit.