The controversy over the big Xarelto trial does not appear to be going away. A new investigation published in the BMJ raises more troubling questions about the ROCKET-AF trial, which compared the novel oral anticoagulant rivaroxaban (Xarelto, Johnson & Johnson) to warfarin in patients with atrial fibrillation. The controversy about the trial first unfolded last…
Alere Withdraws Anticoagulation Monitoring System At Heart Of ROCKET AF Controversy
July 13, 2016 by Leave a Comment
–FDA says the manufacturer has not demonstrated that it has fixed the problem. The Alere INRatio® and INRatio®2 PT/INR Monitoring System are being pulled from the market. Alere, the manufacturer of the devices, which are used by people taking warfarin to monitor their INR, said that the action follows a “collaborative process” with the FDA. The…
New Studies Seek To Allay Concerns Over The ROCKET-AF Trial
February 3, 2016 by Leave a Comment
New post-hoc analyses of ROCKET-AF confirm the main results of the controversial trial, according to a paper published in the New England Journal of Medicine. The papers are a response to disturbing questions about the trial raised last fall. But the new analyses will not fully satisfy some critics of the trial who are calling for…
ROCKET-AF Investigators Seek To Calm Concerns About Trial Reliability
December 13, 2015 by Leave a Comment
(Updated) In response to disturbing questions about the integrity and reliability of crucial data in the ROCKET AF trial, the executive committee of the trial has released a statement saying that they have “conducted a secondary analysis of the trial findings” and that “the findings from the analysis are consistent with the results from the original trial and do not…
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