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Clinical Trial
. 2009;36(6):530-9.

PROCLAIM: pilot study to examine the effects of clopidogrel on inflammatory markers in patients with metabolic syndrome receiving low-dose aspirin

James T Willerson  1 , Greg Cable, Edward T H Yeh; PROCLAIM Investigators
Collaborators, Affiliations
Clinical Trial

PROCLAIM: pilot study to examine the effects of clopidogrel on inflammatory markers in patients with metabolic syndrome receiving low-dose aspirin

James T Willerson et al. Tex Heart Inst J. 2009.

Abstract

Metabolic syndrome is associated with intravascular inflammation, as determined by increased levels of inflammatory biomarkers and an increased risk of ischemic atherothrombotic events. Evidence suggests that atherothrombosis and intravascular inflammation share predictive biomarkers, including high-sensitivity C-reactive protein, CD40 ligand, P-selectin, and N-terminal pro-brain natriuretic peptide. Patients who had metabolic syndrome were randomized to receive clopidogrel 75 mg/day plus aspirin 81 mg/day (n = 89) or placebo plus aspirin 81 mg/day (n = 92) for 9 weeks to assess the efficacy of each treatment in suppression of inflammatory markers. Change from baseline in the levels of high-sensitivity C-reactive protein, CD40 ligand, P-selectin, and N-terminal pro-brain natriuretic peptide at 6 weeks was assessed to evaluate each treatment. There was a significant difference at Week 6 in model-adjusted CD40-ligand levels in favor of clopidogrel plus aspirin compared with placebo plus aspirin in both the intent-to-treat population (difference between least-squares means = -186.5; 95% confidence interval, -342.3 to -30.8; P = 0.02) and the per-protocol population (P = 0.05). No significant differences were observed between the treatment arms for high-sensitivity C-reactive protein, P-selectin, and N-terminal pro-brain natriuretic peptide. There were no deaths or serious adverse events in either treatment arm. Data from this study suggest that clopidogrel can decrease the expression of the CD40-ligand biomarker.

Keywords: Aspirin/therapeutic use; C-reactive protein/drug effects; CD40 ligand/drug effects; P-selectin/drug effects; biological markers/blood; clopidogrel/therapeutic use; inflammation; metabolic syndrome X; platelet aggregation inhibitors/therapeutic use; probrain natriuretic peptide, N-terminal/drug effects.

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Figures

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Fig. 1. Schematic representation of the overall study design. EOS = end of study
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Fig. 2. Study population flow through the study. *Discontinued on Day 1 before taking a single dose of study agent
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Fig. 3. Mean values and standard deviations at baseline (Week 0) and Weeks 2, 4, and 6 for A) hs-CRP, B) CD40 ligand, C) P-selectin, and D) NT-proBNP in the intent-to-treat population. ASA = aspirin; CLO = clopidogrel; hs-CRP = high-sensitivity C-reactive protein; NT-proBNP = N-terminal pro-brain natriuretic peptide; PLA = placebo
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Fig. 4. Change in biomarkers based on a multivariate model analysis from baseline (Week 0) to Week 6 in the levels of A) hs-CRP, B) CD40 ligand, C) P-selectin, and D) NT-proBNP in the intent-to-treat population. Values represent least-squares means (LS means) with SE. ASA = aspirin; CLO = clopidogrel; hs-CRP = high-sensitivity C-reactive protein; NT-proBNP = N-terminal pro-brain natriuretic peptide; PLA = placebo
See this image and copyright information in PMC

References

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