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Safety Issues Raised in Key Trial Supporting Rivaroxaban Use

Defective point-of-care device used in warfarin arm of ROCKET AF trial calls results into question

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THURSDAY, Feb. 4, 2016 (HealthDay News) -- Use of a faulty device in a regulatory drug trial has raised questions relating to rivaroxaban use, according to a feature article published online Feb. 3 in The BMJ.

Deborah Cohen, associate editor from The BMJ, discusses the defective point-of-care device used in one arm of a trial examining use of rivaroxaban to prevent ischemic stroke in non-valvular atrial fibrillation. The companies involved relied on a single trial, ROCKET AF, to gain approval for rivaroxaban from regulators in Europe and the United States.

Cohen notes that concerns have been expressed about these results, with suggestions that care for the warfarin control arm patients in the trial may have been compromised. The point-of-care device used to measure international normalized ratio in patients taking warfarin was recalled in December 2014, as some devices delivered results that were "clinically significantly lower" than a laboratory method; the fault went back to 2002, before the start of the ROCKET AF trial. This could result in an unnecessary increase in warfarin dose, potentially leading to increased risk of bleeding, and questioning the validity of the results.

"The study should be considered of uncertain validity until a more thorough review can be done," Harlan Krumholz, M.D., from Yale University in New Haven., Conn., said in the article, adding that there should be "an investigation by an independent group of experts to quickly determine if there are grounds for retraction."

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