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

This study has been completed.
Sponsor:
Information provided by:
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00455546
First received: March 30, 2007
Last updated: February 1, 2010
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease (CAD)
 Drug: A-002
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Anthera Pharmaceuticals:

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

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

Enrollment: 400
Study Start Date: April 2007
Estimated Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455546

  Hide Study Locations
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
Ukraine
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
Scientific Centre of Endocrine Surgery
Kyiv, Ukraine, 02175
Institute of Gerontology
Kyiv, Ukraine, 04114
Institute of Gerontology AMS
Kyiv, Ukraine, 04114
Kiev Central Hospital #1
Kyiv, Ukraine, 01023
Strazhesko Institute of Cardiology AMS
Kyiv, Ukraine, 03680
City Clinical Hospital No 12
Kyiv, Ukraine, 01103
L'viv Regional State Clinical Treatment and Diagnostics
L'viv, Ukraine, 79015
Hospital of "Radioprylad" Plant
Zaporizhzhya, Ukraine, 69108
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided by Anthera Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00455546     History of Changes
Other Study ID Numbers: AN-CVD-2221
Study First Received: March 30, 2007
Last Updated: February 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
Coronary
Artery
Atherosclerosis
Phospholipase
CAD

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 19, 2013