PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
- Conditions
- Coronary Artery Disease (CAD)
- Registration Number
- NCT00455546
- Lead Sponsor
- Anthera Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
- Secondary Outcome Measures
Name Time Method Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.
Trial Locations
- Locations (32)
Charlotte Cardiovascuar Research
🇺🇸Port Charlotte, Florida, United States
Louisville Cardiology Medical Group
🇺🇸Louisville, Kentucky, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Mobile Heart Specialists
🇺🇸Mobile, Alabama, United States
Cardiology, PC
🇺🇸Syracuse, New York, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Oklahoma Cardiovascular and Hypertension Center
🇺🇸Oklahoma City, Oklahoma, United States
Broward General Medical Center
🇺🇸Ft. Lauderdale, Florida, United States
Kiev Central Hospital #1
🇺🇦Kyiv, Ukraine
Maine Research Associates
🇺🇸Auburn, Maine, United States
Institute of Gerontology AMS
🇺🇦Kyiv, Ukraine
Florida Cardiovascular Institute
🇺🇸Tampa, Florida, United States
Augusta Cardiology Clinic, PC
🇺🇸Augusta, Georgia, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Austin Heart
🇺🇸Austin, Texas, United States
Black Hills Clinical Research Center
🇺🇸Rapid City, South Dakota, United States
Cardiopulmonary Research Science and Technology Institute
🇺🇸Dallas, Texas, United States
Dnipropetrovs'k State Medical Academy
🇺🇦Dnepropetrovs'k, Ukraine
Clinical Research Associates of Tidewater
🇺🇸Norfolk, Virginia, United States
Institute of Therapy of AMS
🇺🇦Kharkiv, Ukraine
Strazhesko Institute of Cardiology AMS
🇺🇦Kyiv, Ukraine
Central Clinical Hospital "Ukrzaliznysti"
🇺🇦Khirkov, Ukraine
Scientific Centre of Endocrine Surgery
🇺🇦Kyiv, Ukraine
City Clinical Hospital No 12
🇺🇦Kyiv, Ukraine
Hospital of "Radioprylad" Plant
🇺🇦Zaporizhzhya, Ukraine
L'viv Regional State Clinical Treatment and Diagnostics
🇺🇦L'viv, Ukraine
Institute of Gerontology
🇺🇦Kyiv, Ukraine
Sonoran Health Specialists
🇺🇸Scottsdale, Arizona, United States
Central Arkansas Research
🇺🇸Hot Springs, Arkansas, United States
Winsconin Heart, SC
🇺🇸Madison, Wisconsin, United States