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

ACTIVE‐W 2006.

Methods RCT comparing clopidogrel plus aspirin versus oral anticoagulation therapy for atrial fibrillation for prevention of vascular events.
Data 6706 patients were randomised (3371 in clopidogrel group/3335 in control group).
Comparisons Onsite assessment (local investigator non blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The outcomes selected were stroke or non‐central nervous systematic embolus or myocardial infarction or vascular death.
Notes The study was identified because it was included in a pooled analysis of 10 RCTs (Pogue 2009). Data related to the number of events in each treatment group resulting from onsite‐assessor and AC assessments were extracted from this meta‐analysis on the primary outcomes of the included studies.
Risk of bias
Item Authors' judgement Description
Method for selecting cases to adjudicate? Yes All suspect events adjudicated were identified by onsite assessor who was not blinded to allocated treatment.