| Methods |
Phase 3, multicentre, randomised, double‐blind, placebo‐controlled, event‐driven trial |
| Participants |
Eligible patients were 80 years of age or older, had a history of nonvalvular atrial fibrillation documented on an electrocardiogram or on a monitor recording obtained within 1 year before consent was given, and had a CHADS2 score of 2 or higher. Eligible patients were also considered to be inappropriate candidates for oral anticoagulants (i.e, warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban) at the recommended therapeutic strength (in the case of warfarin) or at approved doses for one or more of the following reasons: a low creatinine clearance (15 to 30 mL per minute), a history of bleeding from a critical area or organ or gastrointestinal bleeding, low body weight (≤45 kg), continuous use of nonsteroidal antiinflammatory drugs (NSAIDs), or current use of an antiplatelet drug. |
| Interventions |
15 mg of edoxaban once daily versus placebo. |
| Outcomes |
The primary efficacy end point was the composite of stroke or systemic embolism, and the primary safety end point was major bleeding according to the definition of the International Society on Thrombosis and Haemostasis. Secondary efficacy end points included the composite of stroke, systemic embolism, or death from cardiovascular causes; major adverse cardiovascular events (the composite of nonfatal myocardial infarction, nonfatal stroke, nonfatal systemic embolism, or death from cardiovascular causes or bleeding); the composite of stroke, systemic embolism, or death from any cause; net clinical benefit (the composite of stroke, systemic embolism, major bleeding, or death from any cause); and death from any cause. Secondary safety end points included the composite of major bleeding or clinically relevant nonmajor bleeding; clinically relevant nonmajor bleeding; minor bleeding; and all bleeding. |
| Notes |
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