Rivaroxaban (Xarelto) flopped for preventing recurrent strokes and increased bleeding compared with aspirin in top-line results from the phase III NAVIGATE ESUS trial

Well, what is your doctor going to do with this information?  S/he should be able to point to a stroke prevention protocol that top neurologists have written. Unless you think YOUR doctor is tops in the field and has figured out what the answer is.  Guidelines are not good enough, demand a protocol.
Rivaroxaban (Xarelto) flopped for preventing recurrent strokes and increased bleeding compared with aspirin in top-line results from the phase III NAVIGATE ESUS trial
https://www.genengnews.com/gen-news-highlights/xarelto-fails-phase-iii-trial-in-esus/81255021

• Alex Philippidis

• Bayer and Johnson & Johnson’s Janssen Research & Development have acknowledged that their Xarelto^® (rivaroxaban) has failed a Phase III trial assessing the blockbuster anticoagulant in patients with a recent embolic stroke of undetermined source (ESUS).
  The companies said the Phase III NAVIGATE ESUS missed its primary efficacy endpoint of superiority over aspirin in reducing the risk of stroke (ischemic, hemorrhagic, and undefined stroke; transient ischemic attack with positive neuroimaging) and systemic embolism.
  NAVIGATE ESUS was halted early at the recommendation of the study’s Independent Data Monitoring Committee, after a planned interim analysis showed comparable efficacy between patients treated with Xarelto and those treated with aspirin for secondary prevention of stroke and systemic embolism.
  The analysis also concluded that Xarelto stood “little chance” of showing overall benefit if the study were completed, Bayer and Janssen added in separate statements.
  “Patients with ESUS currently have limited treatment options, and the role of anticoagulants in this area remains uncertain. We will now analyze the data from NAVIGATE ESUS to better understand this outcome and its implications,” Joerg Moeller, M.D., member of the executive committee of Bayer's Pharmaceutical Division and head of development, said in a statement.
  He added that patients will be contacted by their physician to switch to aspirin—and that clinical development of Xarelto would continue: “We are committed to continuing the extensive investigation of rivaroxaban for patients at risk of deadly blood clots.”
  The Phase III NAVIGATE ESUS study enrolled 7214 patients from 459 sites across 31 countries. Patients were randomized to either rivaroxaban 15 mg once daily or aspirin 100 mg once daily alone.
  The study’s primary safety endpoint was major bleeding according to the criteria of the International Society on Thrombosis and Haemostasis. Bleeding rates were “very low overall and within the expected range,” Janssen said, though both companies acknowledged that increased bleeding was observed in the rivaroxaban arm compared to the low-dose aspirin arm.
  Bayer and Janssen said a complete data analysis is expected to be presented in 2018, at an unspecified upcoming medical meeting.