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. 2016 Mar 10;2016(3):MR000043. doi: 10.1002/14651858.MR000043.pub2

GUSTO‐IIb 1996.

Methods RCT comparing recombinant hirudin versus heparin for the treatment of acute coronary syndromes.
Data 12,142 patients randomised (6069/6073, respectively in each treatment group. Patients were stratified according to the presence of ST‐segment elevation on the base‐line electrocardiogram (4131 patients) or its absence (8011 patients), with the latter characteristic considered to indicate unstable angina or non–Q‐wave myocardial infarction.
Comparisons Onsite assessment (local investigator blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The outcome selected was a composite outcome of myocardial infarction or reinfarction at 30 days or death from any cause. This was the study's primary outcome.
Notes The study was identified because it was included in a review of six RCTs (Granger 2008). Data related to the number of events in each treatment group resulting from onsite‐assessor and AC assessments were extracted from this review.
Risk of bias
Item Authors' judgement Description
Method for selecting cases to adjudicate? No All suspect events adjudicated were identified by onsite assessor who was blinded to allocated treatment.