ARISTOTLE‐J 2011.
| Methods | Randomised, partially‐blinded, active controlled trial | |
| Participants | 222 Japanese people with a history of documented non‐valvular AF and 1 or more additional risk factors for stroke: age at least 75 years; congestive heart failure with left ventricular ejection fraction of no more than 40%; hypertension requiring medication; diabetes mellitus deemed to require medication on physicians' discretion; history of cerebral infarction or TIA | |
| Interventions | Apixaban (5 mg twice daily or 2.5 mg twice daily; n = 148) versus dose‐adjusted warfarin (target INR 2.0 to 3.0 or 2.0 to 2.6 if age 70 or more years; n = 74) during a predefined 12‐week treatment period | |
| Outcomes | Primary safety outcome: composite of major bleeding and clinically relevant non‐major bleeding (defined by ISTH criteria) Secondary safety and efficacy outcomes: major bleeding; clinically relevant non‐major bleeding; composite of total bleeding events (including minor bleedings); composite of stroke or systemic embolism; composite of stroke, systemic embolism and myocardial infarction or all‐cause death |
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| Notes | Study co‐sponsored by Pfizer and Bristol‐Myers Squibb | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomly assigned to treatment groups |
| Allocation concealment (selection bias) | Low risk | Participants were randomly assigned to treatment groups. Stratification by trial site and prior use of VKA |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Partially blinded design: open‐label warfarin and double‐blind apixaban administration |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Reported efficacy and safety outcomes were adjudicated by an independent committee whose members were not aware of study group assignments |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Primary efficacy outcome analysed in ITT population. All other efficacy and safety outcomes analysed in 'safety population'. Number of participants that discontinued during study and reasons not stated |
| Selective reporting (reporting bias) | Low risk | All predefined efficacy and safety outcomes reported for safety population |
| Other bias | Low risk | _ |