Trial DesignA comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN)
Section snippets
Methods
The RE-ALIGN study is a prospective, randomized, open-label, blinded end-point (PROBE) phase II study comparing dabigatran etexilate with warfarin during a follow-up period of 12 weeks in patients with a mechanical bileaflet heart valve (NCT01452347). The aim of the study is to validate a new dosing regimen based on simulations of PK data from the RE-LY trial,10, 11 for dabigatran etexilate in patients who received a mechanical heart valve.
Discussion
The RE-ALIGN study is the first study to evaluate an alternative to a vitamin K antagonist in patients with a mechanical heart valve. Based on the PK data of dabigatran from the RE-LY study, a dosing algorithm designed to achieve a trough drug level of at least 50 ng/mL will be tested in the study. The patients to be studied in RE-ALIGN will be significantly younger than those in the RE-LY study, and hence, their renal function will be better. Therefore, higher doses of dabigatran etexilate may
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Cited by (0)
Blase A. Canabello, MD served as guest editor for this article.
RCT reg no. NCT01452347.