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J&J, Bayer's Xarelto trial halted early on similar effectiveness versus aspirin


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J&J, Bayer's Xarelto trial halted early on similar effectiveness versus aspirin

Johnson & Johnson and development partner Bayer AG are bringing an early stop to a phase 3 trial of heart drug Xarelto as the trial was unable to show a difference in effectiveness between the drug and the standard of care and aspirin.

The decision to stop the trial is based on the recommendation of the study's independent data monitoring committee.

The trial, which was evaluating the drug for the secondary prevention of stroke and systemic embolism in patients with a recent embolic stroke of undetermined source, showed comparable efficacy between Xarelto and aspirin.

J&J unit Janssen Research & Development LLC and Bayer said the trial had little chance of Xarelto showing an overall benefit versus aspirin if it were to be completed.

Although bleeding rates were very low overall and within the expected range, the Xarelto arm also saw an increase in bleeding compared to aspirin.

Previously, results from a phase 3 study of Xarelto showed that the drug in combination with aspirin can reduce cardiovascular risks by 24% in patients with stable coronary or peripheral artery disease versus aspirin alone.