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Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Nonvalvular Atrial Fibrillation SPORTIF V Trial Presented at American Heart Association Scientific Sessions 2003 Presented By Jonathan L Halperin, M.D.
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www. Clinical trial results.org Ximelagatran (36 mg bid) A novel, oral direct thrombin inhibitor ximelagatran (n = 1,960) Ximelagatran (36 mg bid) A novel, oral direct thrombin inhibitor ximelagatran (n = 1,960) Warfarin Target INR 2.0-3.0 (n = 1,962) Warfarin Target INR 2.0-3.0 (n = 1,962) Endpoints (mean follow-up 20 months): Primary – All strokes (ischemic or hemorrhagic) and systemic embolic events, based on an intention-to-treat analysis for non-inferiority Secondary – Composite of death, stroke, systemic embolism, and MI; and safety variables, specifically bleeding and liver enzyme elevations Endpoints (mean follow-up 20 months): Primary – All strokes (ischemic or hemorrhagic) and systemic embolic events, based on an intention-to-treat analysis for non-inferiority Secondary – Composite of death, stroke, systemic embolism, and MI; and safety variables, specifically bleeding and liver enzyme elevations SPORTIF V Trial AHA 2003 Late Breaking Trials Randomized Double-blind to: 3,922 patients with nonvalvular AF and risk factors for stroke (previous stroke, hypertension, or CHF)
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www. Clinical trial results.org SPORTIF V Trial: Strokes (ischemic or hemorrhagic) and Systemic Embolic Events Warfarin Ximelagatran Intent-to-Treat Absolute 0.45% annual in ximelagatran arm (95% CI -0.13-1.03, p=0.13) Met non-inferiority hypothesis AHA 2003 Late Breaking Trials Event Rate (% per year) In As-Treated Analysis: Absolute 0.55% annual in ximelagatran arm 95% CI -0.06-1.16 p=0.089
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www. Clinical trial results.org SPORTIF V Trial: Bleeding Events AHA 2003 Late Breaking Trials p=NS ICH Major Bleed Event Rate (% per year)
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www. Clinical trial results.org SPORTIF V Trial: Liver Enzyme Elevation Warfarin Ximelagatran ALT >3x ULN p<0.001 AHA 2003 Late Breaking Trials
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www. Clinical trial results.org SPORTIF V Trial: Combined Major Adverse Events On-Treatment Analysis Warfarin Ximelagatran Primary Events + Major Bleeding + Death p=0.527 AHA 2003 Late Breaking Trials Event Rate (% per year)
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