Clinical trial NCT01130246 (phase 3, status: terminated)
Conditions: acute coronary syndrome
ICD codes: I24.0
Drugs: a-002, varespladib methyl, placebo
SMILES: CCC1=C(C(=O)C(N)=O)C2=C(OCC(=O)OC)C=CC=C2N1CC1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    lack of efficacy
  
Eligibility criteria:

        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 minimal
                  exertion with a pattern of increasing frequency or severity, lasting >10 minutes
                  and consistent with myocardial ischemia within 24 hours prior to hospitalization
                  and

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

               -  In addition subjects meeting the above criteria for unstable angina must also
                  have either troponin I, troponin T or CKMB above the LLD but below the 99th
                  percentile of the upper reference limit (URL) and not due to cardioversion or
                  underlying 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., no
                  new Q waves on serial ECGs)and

               -  Increase in cardiac troponin > local limit for the definition of myocardial
                  infarction 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 at
                  least 2 mm in 2 contiguous leads, either of which persisting for longer than 15
                  minutes and

               -  Increase in cardiac troponin > local limit for the definition of myocardial
                  infarction 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 index
             event, 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 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