PLASMA 2 Trial :
Phospholipase Levels And Serological
Markers of Atherosclerosis 2
An Examination of Once Daily (QD) Dosing of A-002 In Subjects With Stable Coronary Artery Disease
Sponsor
Anthera Pharmaceuticals, Inc.
25801 Industrial Blvd
Hayward, CA 94545
USA
Purpose
A-002 represents a novel therapy for the treatment of atherosclerosis and coronary artery disease (CAD). Through the inhibition of activity A-002 may provide multifunctional activity directed against key facets of the disease process, namely a) inflammation, b) atherogenic lipid profiles and c) the atherosclerotic process. Based on data from the recently completed PLASMA study using a BID dosing regimen the PLASMA-2 trial will examine the effects of 2 different once daily doses of A-002 compared with placebo, on sPLA2 enzyme levels and activity after 8 weeks of treatment. In addition, the effect of treatment on inflammatory markers of cardiovascular risk (C-reactive protein [CRP]), lipid levels and lipoprotein subclasses will also be assessed.
Study Design
This is a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive once a day dosing with either placebo tablets or one of 2 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.
Total Enrollment: 138
Eligibility
Inclusion Criteria:
Subjects are eligible for inclusion if they meet the following inclusion criteria:
• Men and women > 18 years of age
• Written informed consent from the subject
• Stable CAD
• 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:
• Planned CABG
• Hospitalization for acute coronary syndrome if troponin level is >0.1 ng/mL in the preceding 6 weeks
• Hospitalization for ST-segment acute myocardial infarction (STEMI) in the preceding 12 weeks
• Subjects with chronic inflammatory disease (e.g., RA), inflammatory bowel disease, recent (12 weeks) systemic or localized infection (the latter requiring clinical intervention), or major surgery
• 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)
• Acute or chronic heart failure as defined by the NYHA classification as functional Class III or Class IV
Location
13 centers in the United States
Contact Information
Medical Monitor:
Colin Hislop, M.D.
Anthera Pharmaceuticals, Inc.
Telephone 510.856.5581
Fax 510.856.5597
Project Manager:
Michael Elliott
Anthera Pharmaceuticals, Inc.
Telephone 510.856.5578
Fax 650.403.0903
Email: melliott@anthera.com