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Stent trial researchers are accused of changing endpoints to suit results

BMJ 2018; 360 doi: https://doi.org/10.1136/bmj.k1298 (Published 20 March 2018) Cite this as: BMJ 2018;360:k1298
  1. Jacqui Wise
  1. London

The organisers of a major clinical trial have been accused of moving the goalposts by quietly changing the study’s primary endpoints shortly before reporting its results.

The change to include softer endpoints to the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial has caused controversy and a row on Twitter.

The $84m (£60m; €68m) trial, funded by the US National Institutes of Health, was designed to provide a clear answer as to whether stents provided more than symptomatic relief to patients who have stable angina.

The investigators changed the primary endpoints of the trial to add admission to hospital for unstable angina or heart failure to the hard endpoints of cardiovascular death and myocardial infarction. There was no public announcement of the change, but in January the trial’s description was updated on the ClinicalTrial.Gov website (https://clinicaltrials.gov/ct2/show/NCT01471522). …

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