The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease

Summary

This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites of clopidogrel. The primary hypothesis is that smoking status will influence the antiplatelet effects and active metabolite concentrations of clopidogrel but will have no impact on prasugrel's antiplatelet effects or active metabolite concentrations.

Timeline

Start

2010-11

Primary completion

2011-09

Completion

2011-09

Outcome

Met primary endpoint

registry analysis (superiority or other test); Prasugrel Smokers vs Clopidogrel Smokers; p <0.0001; Mean Difference (Final Values) 31.8 (95% CI 25.1 to 38.4); Mixed Models Analysis NCT01260584 ↗

paper Greater antiplatelet effects were present after prasugrel treatment regardless of smoking status (p < 0.001 for all comparisons). PMID 23602770 ↗

Publications

• Gurbel PA, Bliden KP, Logan DK, Kereiakes DJ, Lasseter KC, White A, Angiolillo DJ, Nolin TD, Maa JF, Bailey WL, Jakubowski JA, Ojeh CK, Jeong YH, Tantry US, Baker BA. The influence of smoking status on the pharmacokinetics and pharmacodynamics of clopidogrel and prasugrel: the PARADOX study. J Am Coll Cardiol. 2013 Aug 6;62(6):505-12. doi: 10.1016/j.jacc.2013.03.037. Epub 2013 Apr 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Clopidogrel	Small molecule	75 mg	Oral
Subject	Prasugrel	Small molecule	10 mg	Oral

Indications