VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome

Inclusion Criteria:

1. Men and women ≥40 years of age

2. Written informed consent from the subject

3. A diagnosis of unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI) Unstable angina is defined as:

• Chest pain symptomatic of ischemia or angina occurring at rest or on minimalexertion with a pattern of increasing frequency or severity, lasting >10 minutesand consistent with myocardial ischemia within 24 hours prior to hospitalizationand

• New or dynamic ST-segment depression or prominent T-wave inversion changes in atleast 2 contiguous leads and

• In addition subjects meeting the above criteria for unstable angina must alsohave either troponin I, troponin T or CKMB above the LLD but below the 99thpercentile of the upper reference limit (URL) and not due to cardioversion orunderlying cardiovascular (CHF, cardiomyopathy) or renal disease NSTEMI is defined as:

• Chest pain symptomatic of ischemia

• No electrocardiogram (ECG) changes, or ST-depression, or T wave changes(i.e., nonew Q waves on serial ECGs)and

• Increase in cardiac troponin > local limit for the definition of myocardialinfarction or increase in CK-MB isoenzyme > URL STEMI is defined as:

• Chest pain symptomatic of ischemia

• ST segment elevation and associated T wave changes or ST-segment elevation of atleast 2 mm in 2 contiguous leads, either of which persisting for longer than 15minutes and

• Increase in cardiac troponin > local limit for the definition of myocardialinfarction or increase in CK-MB >URL

4. All subjects must have the presence of at least one of the following risk factors:

• Diabetes Mellitus or

• Presence of any 3 of the following characteristics of metabolic syndrome

• Waist circumference >102 cm in males, >88 cm in females

• Serum triglycerides ≥150 mg/dL (≥1.7 mmol/L)

• HDL-C <40 mg/dL (<1 mmol/L) in males, <50 mg/dL (<1.3 mmol/L) in females

• Blood pressure ≥130/85 mmHg

• Plasma glucose ≥110 mg/dL (≥6.1 mmol/L) or

• history of cerebrovascular disease (stroke or TIA) or

• history of peripheral vascular disease or

• previous CABG or

• previous documented myocardial infarction or

• previous coronary revascularization

5. Subjects must be randomized within ≤96 hours of hospital admission for the indexevent, or if already hospitalized, within ≤96 hours of index event diagnosis

6. Revascularization, if required or planned, must occur prior to randomization

Exclusion Criteria:

1. Subjects enrolled in another experimental (interventional)protocol within the past 30days prior to Screening.

2. Subjects treated for cancer within the previous 5 years except for skin basal cellcarcinoma or carcinoma in situ of the cervix, with measures other than a minor,complete surgical excision or radiation therapy (e.g. chemotherapy)

3. The presence of any severe liver disease with cirrhosis, active hepatitis, activechronic hepatitis, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN, biliary obstruction with hyperbilirubinemia (total bilirubin >2 x ULN)

4. Active cholecystitis, gall bladder symptoms, or any hepatobiliary abnormalities

5. The presence of severe renal impairment (creatinine clearance [CrCl] <30 mL/min orcreatinine >3 x ULN),nephrotic syndrome, or subjects undergoing dialysis

6. Uncontrolled diabetes mellitus (known hemoglobin A1c [HbA1c] >11% within the last 1month prior to Screening)

7. Females who are nursing, pregnant, or intend to become pregnant during the time of thestudy, or females of childbearing potential who have a positive pregnancy test duringscreening evaluation. Women of child-bearing potential must also use a reliable methodof birth control during the study and for 1 month following completion of therapy. Areliable method for this study is defined as one of the following: oral or injectablecontraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation,hysterectomy, a double barrier method (diaphragm with spermicidal foam or jelly, or acondom).

8. Subjects who have a history of alcohol or drug abuse within 1 year of study entry

9. Subjects living too far from participating center or unable to return for follow-upvisits

10. Subjects who in the opinion of the Investigator are a poor medical or psychiatric riskfor therapy with an investigational drug, are unreliable, or have an incompleteunderstanding of the study which may affect their ability to take drugs as prescribedor comply with instructions

11. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection

12. Acute bacterial, fungal or viral infection

13. Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unlessthey can be withdrawn

14. Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or ifknown, left ventricular ejection fraction (LVEF) <30

15. Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitralstenosis or mitral regurgitation

16. Ventricular arrhythmias requiring chronic drug treatment or implantablecardioverter-defibrillator (ICD)

17. Subjects with no stenosis or stenosis <50% on angiography, if known

18. Subjects with a pacemaker or persistent left bundle branch block (LBBB)

19. Fasting triglyceride levels of ≥400 mg/dL (4.5 mmol/L)

20. Subjects who have a history of statin intolerance or a significant myopathy orrhabdomyolysis with any lipid altering drugs

21. Subjects currently treated with the maximum labeled dose of a statin and not at LDL-Ctarget for their level of risk as defined by NCEP ATP III