PLASMA Trial: Phospholipase Levels And Serological Markers of Atherosclerosis: A Dose-Response Clinical Pharmacology Study of A-002 In Subjects With Stable Coronary Artery Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Anthera Pharmaceuticals
- Enrollment
- 400
- Locations
- 36
- Primary Endpoint
- Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
Study Overview
Brief Summary
The study will be conducted at up to 80 centers worldwide and will be a double-blind randomized parallel group placebo controlled study among subjects with stable coronary artery disease (CAD). Subjects will be randomized to receive either placebo tablets or one of 4 orally active doses of A-002. The duration of study drug therapy will be 8 weeks.
Detailed Description
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. Non-clinical and clinical data from recent studies have demonstrated the benefit of early and aggressive anti-inflammatory therapy to reduce cardiovascular risk. Recent clinical studies have provided a strong association between levels and cardiovascular event risk. The proposed Phase 2 clinical pharmacology study (Study No. AN-CVD-2221) will examine the effects of 4 different doses of A-002 compared with placebo, on 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 and other soluble biomarkers (e.g., ICAM-1, VCAM-1, TNF, MCP-1 etc) will also be assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
Secondary Outcomes
- Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.