Hamilton General Hospital ( Hamilton, ON).Jewish General Hospital ( Montreal, QC).Hôpital Maisonneuve-Rosemont ( Montreal, QC).The following Canadian hospital emergency rooms are participating in this study: Physicians will be provided with the investigational antidote idarucizumab* as a 'ready to use' solution for infusion. 4 Sites in Canada have now been initiated. 4 Emergency rooms in more than 35 countries worldwide (including Canada) will participate in this study. A pivotal trial is traditionally the last stage of clinical development before market authorization of a medication.Ī global phase III study, RE-VERSE AD™, is underway in patients taking Pradaxa® who have uncontrolled bleeding or require emergency surgery or procedures ( NCT02104947). 1,3 The pivotal study will provide knowledge on the potential of the specific antidote to support the treatment of patients taking Pradaxa®. 2 Boehringer Ingelheim is committed to the development of a Pradaxa®-specific antidote and to improving the standard of care by broadening the range of reversal options available to physicians. John Eikelboom, Associate Professor, Department of Medicine, McMaster University. 'By removing the blood thinning effect of dabigatran in patients, physicians can focus on the other aspects of patient management and treatment.'Īll blood thinning medications carry an increased risk of bleeding. 'For patients who require rapid reversal of Pradaxa's anticoagulant effect, the antidote would provide physicians an additional option beyond their current management strategies,' says Dr.

This is the first antidote to be used to reverse the effects of a new anticoagulant for patients in an emergency situation due to bleeding. 1 Now the antidote will be investigated in the clinical setting in patients taking Pradaxa®. The specific antidote has already demonstrated immediate, complete and sustained reversal of the anticoagulant effect of dabigatran in healthy volunteers. 22, 2014 /CNW/ - Today Boehringer Ingelheim announces the next phase in the clinical development program of the investigational antidote idarucizumab* for rapid reversal of Pradaxa® - induced anticoagulation. Antidote (idarucizumab)* already shown to provide immediate, complete and sustained reversal of anticoagulant effects of dabigatran in healthy adults 1īURLINGTON, ON, Sept.

Reversal of pradaxa anticoagulant