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Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Nonvalvular Atrial Fibrillation

SPORTIF V Trial. Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Nonvalvular Atrial Fibrillation . Presented at American Heart Association Scientific Sessions 2003 Presented By Jonathan L Halperin, M.D. SPORTIF V Trial.

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Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Nonvalvular Atrial Fibrillation

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  1. SPORTIF V Trial Stroke Prevention Using the Oral Direct Thrombin Inhibitor Ximelagatran in Patients With Nonvalvular Atrial Fibrillation Presented at American Heart Association Scientific Sessions 2003 Presented By Jonathan L Halperin, M.D.

  2. SPORTIF V Trial 3,922 patients with nonvalvular AF and risk factors for stroke (previous stroke, hypertension, or CHF) Randomized Double-blind to: • Ximelagatran (36 mg bid) • A novel, oral direct thrombin inhibitor ximelagatran • (n = 1,960) • 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 AHA 2003 Late Breaking Trials

  3. SPORTIF V Trial: Strokes (ischemic or hemorrhagic) and Systemic Embolic Events Intent-to-Treat Absolute 0.45% annual  in ximelagatran arm (95% CI -0.13-1.03, p=0.13) Met non-inferiority hypothesis In As-Treated Analysis: • Absolute 0.55% annual  in ximelagatran arm • 95% CI -0.06-1.16 • p=0.089 Event Rate (% per year) Warfarin Ximelagatran AHA 2003 Late Breaking Trials

  4. SPORTIF V Trial: Bleeding Events p=NS p=NS Event Rate (% per year) ICH Major Bleed AHA 2003 Late Breaking Trials

  5. SPORTIF V Trial: Liver Enzyme Elevation ALT >3x ULN p<0.001 Warfarin Ximelagatran AHA 2003 Late Breaking Trials

  6. SPORTIF V Trial: Combined Major Adverse EventsOn-Treatment Analysis Primary Events + Major Bleeding + Death p=0.527 Event Rate (% per year) Warfarin Ximelagatran AHA 2003 Late Breaking Trials

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