The Study of Quantitative Serial Trends in Lipids With ApolpoproteinA-I Stimulation (SUSTAIN)

This is an interventional treatment trial for Coronary Artery Disease focused on measuring ApolipoproteinA1, HDL-C, Atherosclerosis Read More

Inclusion Criteria:

1. Male and female patient's ≥ 18 years of age with or without documented coronary artery disease
2. Women of child-bearing potential, that is, women not surgically sterilized and between menarche and 1 year post menopause, must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives or levonorgestrel); or a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for one month following the last dose of study drug.
3. HDL-C requirements. Current (Local lab within 60 days or central lab results prior to Visit 1): HDL-C of ≤45 mg/dL (1.17 mmol/L) for females, and HDL-C of ≤40 mg/dL (1.04 mmol/L) for males
4. Taking statin therapy for at least 30 days prior to screening (Visit 1), and in the investigators opinion, an unlikely need for statin dose adjustment during the course of the study.
5. In the opinion of the investigator patients currently on statin therapy other than atorvastatin (10mg, 20mg or 40mg) or rosuvastatin (5mg, 10mg or 20 mg) can be switched to rosuvastatin (5mg, 10mg or 20mg) at Visit 1.

Exclusion Criteria:

1. Clinically significant heart disease which will require coronary bypass, PCI, cardiac transplantation, surgical repair and/or replacement during the course of the study.
2. Coronary artery bypass graft (CABG) procedure within the past 90 days.
3. Previous or current diagnosis of severe heart failure (NYHA Class III-IV) or a documented left ventricular ejection fraction (LVEF) of <25% as determined by contrast left ventriculography, radionuclide ventriculography or echocardiography the absence of an LVEF measurement in a patient without a previous or current diagnosis of heart failure does not prohibit entry into the study.
4. Patients with evidence of cardiac electrophysiologic instability including a history of uncontrolled ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response heart rate of >100 beats per minute at rest within 4 weeks prior to Visit 1.

5. Evidence of renal impairment as determined by any one of the following:

   1. serum creatinine >1.5 mg/dL (>133 micromol/L) at screening Visit 1
   2. a history of dialysis
   3. a history of nephritic syndrome
6. Have hypertension that is uncontrolled defined as 2 consecutive measurements of sitting blood pressure of systolic >160 mm Hg or diastolic >95 mm Hg at Visit 1.
7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive beta-hCG laboratory test (≥5 mIU/mL).
8. Current or recent (within 12 month prior to Visit 1) treatment with immunosuppressants (eg, Cyclosporine).
9. Triglycerides >400 mg/dL at screening Visit 1.
10. Atorvastatin >40 mg daily
11. Rosuvastatin >20 mg daily
12. Use of fibrates any dose or niacin/nicotinic acid 250 mg or more within 90 days prior to Visit 1.
13. Any medical or surgical condition which might significantly alter the absorption, distribution, metabolism or excretion of medication including, but not limited to any of the following: cholecystitis, Crohn's disease, ulcerative colitis, or any gastric bypass alteration.

14. Evidence of hepatic disease as determined by any one of the following:

    • ALT, AST or GGT values >ULN by central lab at screening, Visit 1
    • a history of hepatic encephalopathy,
    • history of Hepatitis B, C or E,
    • a history of esophageal varices, or
    • a history of portocaval shunt.
15. A total bilirubin that is >ULN by central lab at screening, Visit 1.
16. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
17. History or evidence of drug or alcohol abuse within the last 12 months.
18. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
19. Use of other investigational drugs and devices at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
20. History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
21. Any condition that in the opinion of the investigator would confound the evaluation and interpretation of efficacy and/or safety data.
22. Persons directly involved in the execution of this protocol