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

Sponsored by:	Anthera Pharmaceuticals
Information provided by:	Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00455546

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 II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Coronary Artery Disease

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

Show 38 Study Locations

Sponsors and Collaborators

Anthera Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Anthera Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	AN-CVD-2221
Study First Received:	March 30, 2007
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00455546 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:

Coronary
Artery
Atherosclerosis
Phospholipase
CAD

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 10, 2009