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Extension trial to evaluate long term safety of patients randomised into 1160.113 RE-ALIGN study
(RE-ALIGN-EX)

The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…

A Randomised, phase II study to Evaluate the sAfety of oraL dabIGatran etexilate in patients after heart valve replacemeNt. (RE-ALIGN)

The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…