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

Tracking Information
First Received Date ^ICMJE	March 30, 2007
Last Updated Date	February 1, 2010
Start Date ^ICMJE	April 2007
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: March 30, 2007)	Comparison of active and placebo treatments with respect to change from Baseline to Week 8 in sPLA2 levels and activity.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00455546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 30, 2007)	Comparison of active and placebo treatments with respect to change in: Inflammatory markers, lipid and biochemical parameters, and LDL and HDL subclasses.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PLASMA Trial: A Dose-Response Study of A-002 In Subjects With Stable Coronary Artery Disease
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Condition ^ICMJE	Coronary Artery Disease (CAD)
Intervention ^ICMJE	Drug: A-002
Study Arm (s)	Not Provided
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date	September 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Ukraine

Administrative Information
NCT Number ^ICMJE	NCT00455546
Other Study ID Numbers ^ICMJE	AN-CVD-2221
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Anthera Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Anthera Pharmaceuticals
Verification Date	January 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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