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

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

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

What this study is about

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

What this study is about