Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinical indication for coronary angiography
Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria
Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -\< 80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors
Subjects must meet the following criteria at the qualifying coronary catheterization procedure:
Evidence of coronary heart disease (at least one lesion in a native coronary artery that has \> 20% reduction in lumen diameter) or prior percutaneous intervention (PCI)
Left main coronary artery \< 50% reduction in lumen diameter by visual estimation
Target coronary artery for IVUS must be accessible to the IVUS catheter, must not have a \> 50% reduction in lumen diameter within the target segment (and at least 40 mm in length); cannot have undergone prior PCI or coronary artery bypass graft (CABG) and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous myocardial infarction (MI).
You may not be if
Coronary artery bypass graft surgery \< 6 weeks prior to the qualifying IVUS
New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction less than 30%
Uncontrolled cardiac arrhythmia that is not controlled by medications in the 3 months prior to randomization
Known hemorrhagic stroke
Uncontrolled hypertension at randomization
Fasting Triglycerides ≥ 400 mg/dL (4.5 mmol/L) at screening
Type 1 diabetes or poorly controlled type 2 diabetes (hemoglobin A1c \[HbA1c\] \> 9%) at screening.
Moderate to severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²) at screening.
Clareo Health | GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
