Boehringer Ingelheim launches Pradaxa heart valve patient trial

Boehringer Ingelheim has announced the launch of a new clinical trial assessing the efficacy of Pradaxa in preventing valve thrombosis, stroke and systemic embolism among mechanical heart valve patients.

The Re-Align study is the first to evaluate a novel oral anticoagulant as an alternative to warfarin for use in patients with mechanical heart valves requiring anticoagulation therapy.

Currently, heart valve surgery patients require lifelong anticoagulation therapy due to the risk of thromboembolism associated with mechanical valves, but the current standard of care has a number of safety and efficacy concerns associated with it.

The aim of Re-Align is to identify dosing regimens of Pradaxa that are expected to be safe and effective for this patient group.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "The current treatment with vitamin K antagonists is associated with significant limitations, creating a need for novel options which have fewer interactions and do not require regular monitoring."

Earlier this month, the company reported data from a Pradaxa trial showing that it is associated with a significantly shorter interruption of oral anticoagulation therapy compared to warfarin among patients with atrial fibrillation who require surgery.