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Q In patients with non-valvular atrial fibrillation requiring long term oral anticoagulant therapy, is fixed dose oral ximelagatran non-inferior to adjusted dose warfarin for preventing stroke and systemic embolism?
Clinical impact ratings GP/FP/Primary care ★★★★★☆☆ IM/Ambulatory care ★★★★★★☆ Internal medicine★★★★★★☆ Haematology ★★★★★★★ Cardiology ★★★★★★☆
METHODS
Design:
randomised controlled trial (Stroke Prevention using an Oral Thrombin Inhibitor in Atrial Fibrillation [SPORTIF] V).
Allocation:
concealed.*
Blinding:
blinded (clinicians, patients, and outcome assessors).*
Follow-up period:
mean 20 months.
Setting:
409 sites in the US and Canada.
Patients:
3922 patients (mean age 72y, 69% men) who had persistent or paroxysmal non-valvular atrial fibrillation and ⩾1 risk factor for stroke (eg, previous stroke, transient ischaemic attack, or systemic embolism; hypertension; left ventricular dysfunction; and age ⩾75 y or ⩾65 y with coronary disease or diabetes mellitus). …
Footnotes
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↵* See glossary.
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For correspondence: Dr J L Halperin, Mount Sinai Medical Center, New York, NY, USA; jonathan.halperinmsnyuhealth.org
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Source of funding: Astra-Zeneca.