The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients in the RE-LY Trial

Clinical Trials Monday, October 21st, 2013

JACC: October 2013

Objectives  Analyze the impact of dabigatran plasma concentrations, patient demographics and ASA use on frequencies of ischemic strokes/systemic emboli and major bleeds in atrial fibrillation patients .

Background  The efficacy and safety of dabigatran etexilate were demonstrated in the RE-LY trial, but a therapeutic concentration range has not been defined.

Methods  In a prespecified analysis of RE-LY, plasma concentrations of dabigatran were determined in patients treated with dabigatran etexilate 110 mg bid or 150 mg bid and correlated with the clinical outcomes of ischemic stroke/systemic embolism and major bleeding using univariate and multivariate logistic regression and Cox regression models. Patient demographics and ASA use were assessed descriptively and as covariates.Read more

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