Enrollment Criteria

Identifying and enrolling patients for the AIM-HIGH trial may help patients receive the care and medications necessary to achieve their therapeutic goals. Throughout the trial, referring physicians observe participant progress as they continue their primary care visits.

Inclusion Criteria:
Men and women aged 45 and older with the following two criteria:

1. Established Vascular Disease, Defined as One or More of the Following:

a. Documented CAD (one or more of the following primary criteria must be satisfied):

• Documented multivessel CAD (one or more at least 50% stenoses in two major epicardial coronary arteries – with or without antecedent revascularization)
• Documented history of MI
• Hospitalization for unstable angina with objective evidence of ischemia (ST-segment deviation or biomarker positivity) – stable for at least four weeks

b. Documented cerebrovascular or carotid disease (one of the following primary criteria must be satisfied):

• Documented previous ischemic stroke
• Symptomatic carotid artery disease with ≥ 50% carotid arterial stenosis
• Asymptomatic carotid artery disease with ≥ 70% carotid arterial stenosis
• History of carotid revascularization (catheter-based or surgical)

c. Documented Peripheral Arterial Disease (PAD; one or more of the following primary criteria must be satisfied):

• ABI < 0.85 with or without symptoms of intermittent claudication
• History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical)

2. Dyslipidemia defined as: (all 3 must be satisfied)

a. The equivalent, off lipid therapy, of:

• LDL-C < 180 mg/dL (4.7 mmol/L)
• HDL-C ≤ 40 mg/dL (1.0 mmol/L) in men ≤ 50 mg/dL (1.3 mmol/L) in women
• TG ≥ 150 mg/dL (1.7 mmol/L) and ≤ 400 mg/dL (4.5 mmol/L)

b. For patients entering the trial on a statin:

• The upper limit for LDL-C is adjusted according to the specific statin and statin-dose (see Table, section 4.4.1.2)
• HDL-C ≤ 42 mg/dL (1.1 mmol/L) in men or ≤ 53 mg/dL (1.4 mmol/L) in women
• TG ≥ 100 mg/dL (1.1 mmol/L) and ≤ 400 mg/dL (4.5 mmol/L)

Major Exclusion Criteria:

• Coronary Artery Bypass Graft (CABG) surgery within one year of planned enrollment (run-in phase)
• Percutaneous Coronary Intervention (PCI) within 4 weeks of planned enrollment (run-in phase)
• Hospitalization for acute coronary syndrome and discharge within 4 weeks of planned enrollment (run-in phase)
• Fasting glucose ≥ 180 mg/dL (10 mmol/L) or Hb A1C < 9%
• For patients with diabetes, inability or refusal to use a glucometer for home monitoring of blood glucose

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