Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD

Inclusion Criteria

• ACS event of either unstable angina or myocardial infarction 7-90 days prior Visit 1:

Unstable angina: for a qualifying unstable angina event, each of components (a), (b), and (c) must be satisfied: a.) Characteristic ischemic pain or discomfort in chest/associated referral areas, occurring at rest/with minimal exertion b.) ECG changes consistent with acute myocardial ischemia based on new/presumed ST elevation/depression or T-wave inversion c.) Objective evidence of obstructive CAD based on 1+ of the following: i. New/presumed new evidence of myocardial ischemia/infarction by perfusion imaging ii. New/presumed new regional wall motion abnormality iii. Current evidence of at least 1 epicardial coronary artery stenosis ≥70% by coronary angiography iv. Need for coronary revascularization for the index ACS event, including a percutaneous coronary intervention (PCI) with or without coronary stenting.

Prior MI 7-90 days prior screening treated with or without a percutaneous coronary intervention (PCI). For a qualifying event of MI 2 of the following 3 criteria must be satisfied: a.) Characteristic ischemic chest pain/pain in associated referral areas b.) Dynamic elevation of troponin T/I or CKMB if troponinT/I is unavailable at local lab (at least >ULN for lab) c.) Development of new Q-waves in ≥2 adjacent ECG leads or development of new dominant R wave in V1

• Documented diagnosis of T2DM (1+ of the following criteria): Documented history of T2DM, History of taking diabetes medication, and/or HbA1c ≥6.5% at Visit 1
• For males HDL-C 100bpm at rest w/in 4 wks prior Visit 1
• CABG w/in 90 days prior Visit 1
• Evidence of severe renal impairment as determined by either eGFR 180 mmHg or diastolic>100 mmHg at Visit 1
• Treatment w/ immunosuppressants w/in 12 mos prior Visit 1
• Use of fibrates at any dose or niacin/nicotinic acid 250+ mg w/in 30 days prior Visit 1
• Known allergy/sensitivity to any ingredient in IMP
• History of intolerance to atorvastatin/rosuvastatin
• Triglycerides>400 mg/dL (4.52 mmol/L) at Visit 1
• Any medical/surgical condition which might significantly alter absorption, distribution, metabolism or excretion of medication
• Evidence of cirrhosis from liver imaging/biopsy, history of hepatic encephalopathy, esophageal/gastric varices, active hepatitis or prior porta-caval shunt procedure or a Child-Pugh score of ≥5 points
• ALT/AST>1.5xULN by central lab at Visit 1
• Tot. bilirubin>ULN by central lab at Visit 1
• History of malignancy of any organ syst treated/untreated w/in the past 2 yrs whether or not there is evidence of local recurrence/metastases except localized basal skin cell carcinoma
• History/evidence of drug/alcohol abuse w/in 12 mos of Visit 1
• Pregnancy
• Any condition which may place subject at higher risk from his/her participation in the study or is likely to prevent subject from completing/complying w/ requirements of study
• Use of other investigational drugs and devices w/in 30 days or 5 half-lives of Visit 1, whichever is longer
• History of noncompliance to medical regimens or unwillingness to comply w/ study protocol
• Any condition that would confound the evaluation/interpretation of efficacy and/or safety data
• Persons directly involved in execution of this protocol