PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
PLASMA
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
1 other identifier
interventional
400
2 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2007
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedFirst Posted
Study publicly available on registry
April 3, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFebruary 2, 2010
January 1, 2008
March 30, 2007
February 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
Secondary Outcomes (1)
Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Mobile Heart Specialists
Mobile, Alabama, 36608, United States
Sonoran Health Specialists
Scottsdale, Arizona, 85260, United States
Central Arkansas Research
Hot Springs, Arkansas, 71913, United States
Broward General Medical Center
Fort Lauderdale, Florida, 33316, United States
Unknown Facility
Hudson, Florida, United States
Charlotte Cardiovascuar Research
Port Charlotte, Florida, 339521, United States
Florida Cardiovascular Institute
Tampa, Florida, 33609, United States
Augusta Cardiology Clinic, PC
Augusta, Georgia, 30901, United States
Louisville Cardiology Medical Group
Louisville, Kentucky, 40207, United States
Maine Research Associates
Auburn, Maine, 04210, United States
University of Michigan
Ann Arbor, Michigan, 48106, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
United Medical Associates
Binghamton, New York, 13901, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
Cardiology, PC
Syracuse, New York, 13210, United States
Oklahoma Cardiovascular and Hypertension Center
Oklahoma City, Oklahoma, 73132, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105, United States
Unknown Facility
Camp Hill, Pennsylvania, United States
Black Hills Clinical Research Center
Rapid City, South Dakota, 57701, United States
Austin Heart
Austin, Texas, 78705, United States
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Winsconin Heart, SC
Madison, Wisconsin, 53715, United States
Strazhesko Institute of Cardiology AMS
Kyiv, 03680, Ukraine
Dnipropetrovs'k State Medical Academy
Dnepropetrovs'k, 49027, Ukraine
Institute of Therapy of AMS
Kharkiv, 61039, Ukraine
Central Clinical Hospital "Ukrzaliznysti"
Khirkov, 61018, Ukraine
Strazhesko Institute of Cardiology AMS
Kviv, 03680, Ukraine
Kiev Central Hospital #1
Kyiv, 01023, Ukraine
City Clinical Hospital No 12
Kyiv, 01103, Ukraine
Scientific Centre of Endocrine Surgery
Kyiv, 02175, Ukraine
Strazhesko Institute of Cardiology AMS
Kyiv, 03680, Ukraine
Institute of Gerontology AMS
Kyiv, 04114, Ukraine
Institute of Gerontology
Kyiv, 04114, Ukraine
L'viv Regional State Clinical Treatment and Diagnostics
Lviv, 79015, Ukraine
Hospital of "Radioprylad" Plant
Zaporizhzhya, 69108, Ukraine
Related Publications (1)
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.
PMID: 19231633DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 30, 2007
First Posted
April 3, 2007
Study Start
April 1, 2007
Study Completion
September 1, 2007
Last Updated
February 2, 2010
Record last verified: 2008-01