LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)

Exclusion Criteria

• •1. Subject was clinically unstable:
• •1. Hypotension, defined as sustained systolic blood pressure of \<90 mmHg due to cardiac failure with associated symptoms;
• •2. Unstable or severe pulmonary edema/decompensated congestive heart failure;
• •3. Acute mitral regurgitation or acute ventricular septal defect;
• •4. Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
• •5. Ongoing Non-STEMI with biomarkers (cardiac troponin) still rising
• •6. Recent STEMI (≤7 days prior to randomization)
• •7. Recurrent symptoms of cardiac ischemia
• •2. Moderate to severe heart failure (New York Heart Association \[NYHA\] Functional Classification III or IV) or last known left ventricular ejection farction (LVEF) \<40%.
• •3. Severe renal dysfunction, defined as creatinine clearance \<30 mL/min or estimated glomerular filtration (eGFR) rate less than 30 ml/min/1.73 m2, or requirement for peritoneal dialysis or hemodialysis for renal insufficiency.
• •4. History of hemorrhagic stroke or unknown classified stroke.
• •5. Uncontrolled or recurrent ventricular tachycardia (such as ventricular fibrillation, recurrent and highly symptomatic ventricular tachycardia, complete heart block, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications).
• •6. Uncontrolled hypertension (greater than 180 mm Hg systolic and/or greater than 110 mm Hg diastolic at randomization visit).
• •7. History or clinical evidence of active liver disease or hepatic dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × upper limit of normal (ULN), or total bilirubin \> 2 × ULN.
• •8. Unexplained elevated creatine kinase (CK) concentration \>5 × ULN or elevation due to known muscle disease.
• •9. Planned or expected cardiac surgery, PCI or carotid stenting, or planned major noncardiac surgery during the study period. If angiography or revascularization is planned, patients may be screened and enrolled after all such planned procedures are completed.
• •10. Active Malignancy (except nonmelanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) including those patients requiring surgery, chemotherapy, and/or radiation in the past 3 years.
• •11. Drug or alcohol abuse, and inability/unwillingness to abstain from drug abuse and excessive alcohol consumption during the study.
• •12. Severe, concomitant noncardiovascular disease that is expected to reduce life expectancy to \<3 years
• •13. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies), or receiving other investigational agent(s)
• •14. Subject has received drugs via a systemic route that have known major interactions with background statin therapy (eg, itraconazole, ketoconazole, and other antifungal azoles, erythromycin, clarithromycin, or cyclosporine nefazodone) within 1 month prior to randomization or is likely to require such treatment during the study period.
• •15. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)
• •16. Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
• •17. Any uncontrolled or serious disease, or any medical or surgical condition (such as known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction, or a chronic disease or infection \[eg, HIV\]), that may either interfere with participation in the clinical study and is not currently stable and appropriately managed in the judgment of the investigator, and/or put the subject at significant risk (according to investigator's judgment) if he/she participates in the clinical study.
• •18. Mental/psychological impairment/neurocognitive disorder, or any other reason to expect patient difficulty in complying with the requirements of the study or understanding the goal and potential risks of participating in the study