PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease (PLASMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455546
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : February 2, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease (CAD) Drug: A-002 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.

Secondary Outcome Measures :
  1. Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00455546

  Hide Study Locations
United States, Alabama
Mobile Heart Specialists
Mobile, Alabama, United States, 36608
United States, Arizona
Sonoran Health Specialists
Scottsdale, Arizona, United States, 85260
United States, Arkansas
Central Arkansas Research
Hot Springs, Arkansas, United States, 71913
United States, Florida
Broward General Medical Center
Ft. Lauderdale, Florida, United States, 33316
Hudson, Florida, United States
Charlotte Cardiovascuar Research
Port Charlotte, Florida, United States, 339521
Florida Cardiovascular Institute
Tampa, Florida, United States, 33609
United States, Georgia
Augusta Cardiology Clinic, PC
Augusta, Georgia, United States, 30901
United States, Kentucky
Louisville Cardiology Medical Group
Louisville, Kentucky, United States, 40207
United States, Maine
Maine Research Associates
Auburn, Maine, United States, 04210
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48106
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, New York
United Medical Associates
Binghamton, New York, United States, 13901
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
Cardiology, PC
Syracuse, New York, United States, 13210
United States, Oklahoma
Oklahoma Cardiovascular and Hypertension Center
Oklahoma City, Oklahoma, United States, 73132
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Camp Hill, Pennsylvania, United States
United States, South Dakota
Black Hills Clinical Research Center
Rapid City, South Dakota, United States, 57701
United States, Texas
Austin Heart
Austin, Texas, United States, 78705
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, United States, 75230
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Winsconin Heart, SC
Madison, Wisconsin, United States, 53715
Strazhesko Institute of Cardiology AMS
Kyiv, 03680, Ukraine
Dnipropetrovs'k State Medical Academy
Dnepropetrovs'k, Ukraine, 49027
Institute of Therapy of AMS
Kharkiv, Ukraine, 61039
Central Clinical Hospital "Ukrzaliznysti"
Khirkov, Ukraine, 61018
Strazhesko Institute of Cardiology AMS
Kviv, Ukraine, 03680
Kiev Central Hospital #1
Kyiv, Ukraine, 01023
City Clinical Hospital No 12
Kyiv, Ukraine, 01103
Scientific Centre of Endocrine Surgery
Kyiv, Ukraine, 02175
Strazhesko Institute of Cardiology AMS
Kyiv, Ukraine, 03680
Institute of Gerontology AMS
Kyiv, Ukraine, 04114
Institute of Gerontology
Kyiv, Ukraine, 04114
L'viv Regional State Clinical Treatment and Diagnostics
L'viv, Ukraine, 79015
Hospital of "Radioprylad" Plant
Zaporizhzhya, Ukraine, 69108
Sponsors and Collaborators
Anthera Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00455546     History of Changes
Other Study ID Numbers: AN-CVD-2221
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: January 2008

Keywords provided by Anthera Pharmaceuticals:

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Varespladib methyl
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action