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\<40 mg/dL(1.04 mmol/L), for females HDL-C\<45 mg/dL(1.17 mmol/L) at Visit 1 * Subjects currently not on high intensity statin therapy could start rosuvastatin at Visit 1 and those currently on therapy besides atorvastatin/rosuvastatin can be switched to rosuvastatin at Visit 1 * Female subjects of non-childbearing potential (post-surgical sterilization/post-menopausal) or if childbearing potential have neg urine pregnancy test and be willing and able to use non-hormonal birth control (non-hormonal IUD, condom or diaphragm) or remain abstinent from Screening to Follow-up Visit * Give signed informed consent Exclusion Criteria: * Heart disease which will w/in 90 days of Visit 1 likely need coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement * Previous/current diagnosis of severe heart failure or documented LVEF\<25% determined by contrast left ventriculography, radionuclide ventriculography or echocardiography. Absence of LVEF measurement in subject w/out a previous/current diagnosis of heart failure does not exclude entry into study * Evidence of cardiac EP instability incl. history of uncontrolled ventricular arrhythmias, atrial fibrillation/flutter or supraventricular tachycardias w/ a ventricular response HR\>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\<30 mL/min/1.7m2 at Visit 1 or current need for dialysis * Uncontrolled hypertension defined as 2 consecutive measurements of sitting BP of systolic\>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