The primary outcome was clinically significant UGI bleeding, defined as clinically significant bleeding
necessitating transfusion of red cells, associated with haemodynamic compromise, or resulting in decrease of haemoglobin >20 g/l.
2) In TRITON-TIMI 38, Effient reduced ischemic events (mainly nonfatal MIs) when compared with Plavix, but its choice as an oral antiplatelet agent in patients with ACS who are to be managed with PCI must be balanced against the increased risk of clinically significant bleeding
relative to Plavix.
In any clinically significant bleeding
site, attempts should be made to exclude surgical causes of bleeding, to reverse, when possible, the etiologic factors contributing to the coagulopathy (eg, hypoperfusion, acidosis, hypothermia), and to correct coagulation function.
The primary endpoint of the Rapinex 40mg Phase III trial, the occurrence of clinically significant bleeding
, was the same as that seen in the IV cimetidine trial that led to its approval.
029) with clinically significant bleeding
(WHO Grades 2-4) observed in fewer PROMACTA patients (16%) than placebo patients (36%).
The primary endpoint of the study, the occurrence of clinically significant bleeding
, was the same used in the cimetidine trial which led to its approval.
The results showed that treatment with rNAPc2, in addition to standard antithrombotic therapies in patients with ACS, resulted in a dose-related inhibition of thrombin generation without an increase in clinically significant bleeding