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PLASMA Trial: A Dose-Response...

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

Last Updated: 2010-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease (CAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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A-002

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers