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

Exclusion Criteria

• •1. Subjects enrolled in another experimental (interventional)protocol within the past 30 days prior to Screening.
• •2. Subjects treated for cancer within the previous 5 years except for skin basal cell carcinoma 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, active chronic 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 or creatinine \>3 x ULN),nephrotic syndrome, or subjects undergoing dialysis
• •6. Uncontrolled diabetes mellitus (known hemoglobin A1c \[HbA1c\] \>11% within the last 1 month prior to Screening)
• •7. Females who are nursing, pregnant, or intend to become pregnant during the time of the study, or females of childbearing potential who have a positive pregnancy test during screening evaluation. Women of child-bearing potential must also use a reliable method of birth control during the study and for 1 month following completion of therapy. A reliable method for this study is defined as one of the following: oral or injectable contraceptives, intrauterine device (IUD), contraceptive implants, tubal ligation, hysterectomy, a double barrier method (diaphragm with spermicidal foam or jelly, or a condom).
• •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-up visits
• •10. Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational drug, are unreliable, or have an incomplete understanding of the study which may affect their ability to take drugs as prescribed or 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 Subjects currently taking drugs that are potent inhibitors of cytochrome P450 unless they can be withdrawn
• •14. Subjects with New York Heart Association (NYHA) Class III or IV heart failure, or if known, left ventricular ejection fraction (LVEF) \<30
• •15. Subjects with moderate or severe aortic stenosis, aortic regurgitation, mitral stenosis or mitral regurgitation
• •16. Ventricular arrhythmias requiring chronic drug treatment or implantable cardioverter-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 or rhabdomyolysis with any lipid altering drugs
• •21. Subjects currently treated with the maximum labeled dose of a statin and not at LDL-C target for their level of risk as defined by NCEP ATP III