Heart Attack Heart Disease
Conditions
Interventions
Following confirmation of eligibility, subjects will be randomized to A-002 500
mg QD or placebo plus atorvastatin. The dose of atorvastatin to be used will be
at the discretion of the treating clin
Sponsors
Anthera Pharmaceuticals, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men and women *40 years of age 2. Written informed consent from the subject 3. All subjects must have the presence of at least one of the following risk factors: i. Diabetes Mellitus or ii. 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 50%) - history of peripheral vascular disease or - previous CABG or - previous documented myocardial infarction or - previous coronary revascularization 4. 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 5. Percutenous revascularization, if required or planned, must occur prior to randomization
Exclusion criteria
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 hepato-biliary abnormalities 5. The presence of severe renal impairment (creatinine clearance [CrCl] 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 child-bearing potential who have a positive pregnancy test during screening evaluation. Women of childbearing 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 followup visits 10. Subjects who have a history of statin intolerance or a significant myopathy or rhabdomyolysis with any lipid-altering drugs 11. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to determine whether 16 weeks of treatment with A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the hazard of the first occurrence of the combined endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary objective of the study is to determine whether A-002 plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing the occurrence of the hazard of the combined endpoint of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization or multiple occurrences of the nonfatal components of the composite primary endpoint | — |
Countries
Netherlands
Outcome results
None listed