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

March 30, 2007
February 1, 2010
April 2007
Not Provided
Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
Same as current
Complete list of historical versions of study NCT00455546 on ClinicalTrials.gov Archive Site
Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.
Same as current
Not Provided
Not Provided
 
PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Coronary Artery Disease (CAD)
Drug: A-002
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
September 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Ukraine
 
NCT00455546
AN-CVD-2221
No
Not Provided
Anthera Pharmaceuticals
Not Provided
Not Provided
Anthera Pharmaceuticals
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP