Clinical trial NCT00525954 (phase 2, status: completed)
Conditions: coronary artery disease
ICD codes: I25.10, I25.110, I25.119, I25.111, I25.118
Drugs: a-002
SMILES: CCC1=C(C(=O)C(N)=O)C2=C(OCC(=O)OC)C=CC=C2N1CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

        Subjects are eligible for inclusion if they meet the following inclusion criteria:

          1. Men and women ≥18 years of age

          2. Written informed consent from the subject

          3. Stable CAD

          4. Stable medical condition, will be compliant and able to comply with the requirements
             of the protocol

        Exclusion Criteria:

        Subjects must NOT meet any of the following exclusion criteria:

          1. Planned coronary artery bypass surgery (CABG)

          2. Acute or chronic heart failure as defined by the New York Heart Association (NYHA)
             classification as functional Class III or Class IV

          3. Hospitalization for acute coronary syndrome (ACS) if troponin >0.1 ng/mL in the
             preceding 6 weeks

          4. Hospitalization for ST-segment elevation acute myocardial infarction (STEMI) in the
             preceding 12 weeks

          5. Subjects with chronic inflammatory disease (e.g., rheumatoid arthritis), inflammatory
             bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring
             clinical intervention), or major surgery

          6. hs-CRP ≥15 mg/L repeated on at least 2 occasions >24 hours apart due to
             non-cardiovascular systemic inflammatory conditions (e.g., rheumatoid disease)

          7. Subjects enrolled in another experimental (interventional) protocol within the past 30
             days prior to Screening or prior experience with A-002.

          8. 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 (e.g., chemotherapy), or radiation therapy

          9. Subjects who have received immunosuppressant therapy within 30 days prior to entry

         10. Subjects who have received anti-tumor necrosis factor (for example, infliximab)
             therapy within 6 months prior to entry

         11. The presence of severe liver disease with cirrhosis, recent active hepatitis, active
             chronic hepatitis, ALT or AST >3 x upper limit of normal, biliary obstruction with
             hyperbilirubinemia (total bilirubin >2 x upper limit of normal)

         12. Active cholecystitis, gall bladder symptoms, or potential hepato-biliary abnormalities

         13. The presence of moderate or severe renal impairment (CrCl <60 mL/min or creatinine
             >1.5 x upper limit of normal), nephrotic syndrome, or subjects undergoing dialysis

         14. Uncontrolled diabetes mellitus (known HbA1c >11% within the last 1 month prior to
             screening)

         15. Females who are nursing, pregnant, or intend to become pregnant during the time of the
             study, or subjects who have a positive serum pregnancy test at Visit 1 (if the subject
             is a female of child-bearing potential). 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).

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

         17. Subject living too far from participating center or unable to return for follow-up
             visits

         18. 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

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

         20. Treatment with any systemic corticosteroid within the 30-day period prior to study
             entry or the use of inhaled steroids within the 14-day period prior to study entry