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

Primary Purpose

Coronary Artery Disease (CAD)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
A-002
Sponsored by
Anthera Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease (CAD) focused on measuring Coronary, Artery, Atherosclerosis, Phospholipase, CAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mobile Heart Specialists
  • Sonoran Health Specialists
  • Central Arkansas Research
  • Broward General Medical Center
  • Charlotte Cardiovascuar Research
  • Florida Cardiovascular Institute
  • Augusta Cardiology Clinic, PC
  • Louisville Cardiology Medical Group
  • Maine Research Associates
  • University of Michigan
  • Henry Ford Hospital
  • United Medical Associates
  • Regional Clinical Research, Inc.
  • Cardiology, PC
  • Oklahoma Cardiovascular and Hypertension Center
  • Lehigh Valley Hospital
  • Black Hills Clinical Research Center
  • Austin Heart
  • Cardiopulmonary Research Science and Technology Institute
  • Clinical Research Associates of Tidewater
  • Winsconin Heart, SC
  • Strazhesko Institute of Cardiology AMS
  • Dnipropetrovs'k State Medical Academy
  • Institute of Therapy of AMS
  • Central Clinical Hospital "Ukrzaliznysti"
  • Strazhesko Institute of Cardiology AMS
  • Kiev Central Hospital #1
  • City Clinical Hospital No 12
  • Scientific Centre of Endocrine Surgery
  • Strazhesko Institute of Cardiology AMS
  • Institute of Gerontology AMS
  • Institute of Gerontology
  • L'viv Regional State Clinical Treatment and Diagnostics
  • Hospital of "Radioprylad" Plant

Outcomes

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.

Full Information

First Posted
March 30, 2007
Last Updated
February 1, 2010
Sponsor
Anthera Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00455546
Brief Title
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
Acronym
PLASMA
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 Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Anthera Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
Keywords
Coronary, Artery, Atherosclerosis, Phospholipase, CAD

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
A-002
Primary Outcome Measure Information:
Title
Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
Secondary Outcome Measure Information:
Title
Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
19231633
Citation
Rosenson RS, Hislop C, McConnell D, Elliott M, Stasiv Y, Wang N, Waters DD; PLASMA Investigators. Effects of 1-H-indole-3-glyoxamide (A-002) on concentration of secretory phospholipase A2 (PLASMA study): a phase II double-blind, randomised, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):649-58. doi: 10.1016/S0140-6736(09)60403-7. Erratum In: Lancet. 2009 May 9-2009 May15;373(9675):1606. Lancet.2011 Apr 30;377(9776):1494.
Results Reference
derived

Learn more about this trial

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

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