Pivotal NOAC trial may have been compromised: BMJ
By Anna Evangeli and Rada Rouse
Update, 8 February: The European Medicines Agency (EMA) has concluded after an investigation that a defect with the INR device used in the ROCKET AF trial does not change its assessment of the overall safety or benefit-risk balance of rivaroxaban.
Any incorrect measurements obtained wih the defective device would have had "only a marginal effect" on the study results, the EMA said in a statement.
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RESULTS from a pivotal trial on the