Coronary Artery Disease
Conditions
Interventions
Sponsors
Maruyama Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fasting LDL-C local lab value at the Screening Visit of either i) >=100 mg/dL if on statin therapy but not on a maximally tolerated statin therapy; ii) >=150 mg/dL if statin naive and without documented statin intolerance; or iii) >=70 mg/dL if on a stable (>=4 weeks) dose of maximally tolerated statin therapy or if statin intolerant. 2.Participants may be pre-identified based on a CCTA or an invasive angiography that is performed as part of standard of care within 12 months prior to the participant's Screening Visit demonstrating: Presence of coronary artery plaque with visual diameter stenosis 50% but Fractional Flow Reserve (FFR) >0.8 by special wire measurement (CCTA or coronary angiography) 3.Fasting LDL-C local lab value >=70 mg/dL at the assessment performed during the Statin Optimization Period 3 Visit for participants going through the Statin Optimization Period. 4.Participants having Non-Obstructive Coronary Artery (NOCA) confirmed by CCTA with FFRct >0.8 and CT-adapted Leaman score >5 or coronary artery plaque with visual diameter stenosis >50% but with FFRct >0.8 and CT-adapted Leaman score >5 without previous cardiovascular events. 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 of FFRct >0.8 and CT-adapted Leaman score >5, which will be assessed by the Imaging Core Lab. 5.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.
Exclusion criteria
Exclusion criteria: 1.Previous cardiovascular events history including myocardial infarction (MI), or prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)]. 2.Planned revascularization (PCI) or (CABG). 3.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 50% but FFR 180 mmHg or diastolic blood pressure >110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy. 10.Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit. 11.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. 12.Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in total coronary atheroma volume | — |
Countries
Argentina, Belgium, Brazil, Canada, Chile, China, France, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed