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ATLAS Trial Design Blamed For Missing Data On Xarelto ACS Use

Executive Summary

Some members of FDA’s Cardiovascular and Renal Drugs Advisory Committee questioned whether the high rate of study dropouts and consent withdrawals in rivaroxaban’s pivotal trial for acute coronary syndromes resulted from elements of the trial’s design, including patient consent and follow-up procedures and the primary analysis.

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Recapturing Missing Vital Status Not Enough To Rescue Xarelto ACS Claim

Janssen made “heroic” efforts to track down vital status for subjects who withdrew from the ATLAS acute coronary syndromes trial, but the data added little to the interpretation of the primary composite endpoint and had a slightly negative effect on all-cause mortality results, FDA advisory committee members said.

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The agency’s decision not to approve the Factor Xa inhibitor for treating acute coronary syndrome patients follows a negative recommendation by an FDA advisory committee, which was concerned about missing data in the pivotal ATLAS trial. FDA may be seeking more clarity on the issue of missing vital status follow-up for patients who withdrew consent in that study.

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