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document
PROCLAIM : pilot study to examine the effects of clopidogrel on inflammatory markers in patients with metabolic syndrome receiving low-dose aspirin . 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 .
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Intervention_Pharmacological
clopidogrel
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Intervention_Pharmacological
aspirin
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Intervention_Pharmacological
clopidogrel 75 mg/day
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Intervention_Pharmacological
aspirin 81 mg/day
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Intervention_Control
placebo
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Intervention_Pharmacological
aspirin 81 mg/day
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Intervention_Pharmacological
clopidogrel
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Intervention_Pharmacological
aspirin
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Intervention_Control
placebo
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Intervention_Pharmacological
aspirin
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Intervention_Pharmacological
clopidogrel
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Outcome_Physical
high-sensitivity C-reactive protein , CD40 ligand , P-selectin ,
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Outcome_Physical
N-terminal pro-brain natriuretic peptide
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Outcome_Physical
model-adjusted CD40-ligand levels
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Outcome_Physical
high-sensitivity C-reactive protein
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Outcome_Physical
P-selectin
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Outcome_Physical
N-terminal pro-brain natriuretic peptide
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Outcome_Adverse-effects
deaths
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Outcome_Adverse-effects
serious adverse events
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Outcome_Physical
expression of the CD40-ligand biomarker .
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Participant_Condition
patients with metabolic syndrome receiving low-dose aspirin .
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Participant_Age
Patients who had metabolic syndrome