SPORTIF


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AcronymDefinition
SPORTIFStroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Atrial Fibrillation (study)
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The primary end point in SPORTIF V was all strokes (both hemorrhagic and ischemic) and systemic embolic events.
The SPORTIF data indicate a solid clinical benefit to ximelagatran, and publication of the study in JAMA adds to the body of evidence about the potential of this therapy," said Jonathan L.
Professor Gary Ford, Consultant Stroke Physician the Freeman Hospital Stroke Service, Newcastle upon Tyne, and Principal Investigator in the SPORTIF programme in the UK said "These results show that ximelagatran is as effective in preventing stroke as extremely well-controlled warfarin and avoids the need for long-term monitoring.
SPORTIF V was designed as a non-inferiority(c) study to compare oral Exanta with the current standard treatment, dose-adjusted warfarin in preventing stroke and systemic embolic events (SEE) in atrial fibrillation, and the results support the findings of the SPORTIF III study.
The primary endpoint of SPORTIF III was met in demonstrating that fixed dose twice daily 36mg oral Exanta compares favourably with well-controlled dose-adjusted warfarin in prevention of stroke and SEE in patients with AF (40 Exanta vs 56 warfarin events, ITT population).
Note C - SPORTIF stands for Stroke Prevention by ORal Thrombin Inhibitor in atrial Fibrillation, and is the largest-ever stroke prevention study in atrial fibrillation to date.
In SPORTIF III, there were 29 major (requiring hospitalization) bleeding events in the group receiving EXANTA compared to 41 in the warfarin arm (p=ns).
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