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Ximelagatran was not inferior to warfarin for preventing stroke and systemic embolism in non-valvular atrial fibrillation

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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 ★★★★★★☆


Embedded ImageDesign:

randomised controlled trial (Stroke Prevention using an Oral Thrombin Inhibitor in Atrial Fibrillation [SPORTIF] V).

Embedded ImageAllocation:


Embedded ImageBlinding:

blinded (clinicians, patients, and outcome assessors).*

Embedded ImageFollow-up period:

mean 20 months.

Embedded ImageSetting:

409 sites in the US and Canada.

Embedded ImagePatients:

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). …

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  • * See glossary.

  • For correspondence: Dr J L Halperin, Mount Sinai Medical Center, New York, NY, USA;

  • Source of funding: Astra-Zeneca.