This interim analysis included 90 patients who received idarucizumab (51 patients in group A and 39 in group B). A key secondary end point was the restoration of hemostasis. The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the determination at a central laboratory of the dilute thrombin time or ecarin clotting time. We undertook this prospective cohort study to determine the safety of 5 g of intravenous idarucizumab and its capacity to reverse the anticoagulant effects of dabigatran in patients who had serious bleeding (group A) or required an urgent procedure (group B). Idarucizumab, an antibody fragment, was developed to reverse the anticoagulant effects of dabigatran. Specific reversal agents for non–vitamin K antagonist oral anticoagulants are lacking.

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Cost of idarucizumab