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Study of dabigatran in artificial heart valve patients halted

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Boehringer Ingelheim today announced the decision to discontinue the phase 2 RE-ALIGN trial, which was designed to evaluate the use of dabigatran etexilate in patients with artficial heart valves, according to a press release.

The trial was stopped because interim data indicated that this patient population was not achieving optimal results with the dosing regimen, the release stated.

Initiated in October 2011, RE-ALIGN was a randomized, open-label trial comparing warfarin with three doses of dabigatran (Pradaxa, Boehringer Ingelheim) in approximately 400 patients with artificial heart valves. Currently, the drug is not approved or recommended for use in this patient population.