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

February 1, 2010 updated by: Anthera Pharmaceuticals

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Enrollment (Actual)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion

September 1, 2007

Study Registration Dates

First Submitted

March 30, 2007

First Submitted That Met QC Criteria

March 30, 2007

First Posted (Estimate)

April 3, 2007

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

January 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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