Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial.

  • Albers GW Frison L, Grind M, Nevinson M, Partridge S, Halperin JL, Horrow J, Olsson SB, Petersen P, Vahanian A, SPORTIF Executive Steering Committee for the SPORTIF V Investigators D
  • Albers G
  • Diener H
 et al. 
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Abstract

CONTEXT: In patients with nonvalvular atrial fibrillation, warfarin prevents ischemic stroke, but dose adjustment, coagulation monitoring, and bleeding limit its use., OBJECTIVE: To compare the efficacy of the oral direct thrombin inhibitor ximelagatran with warfarin for prevention of stroke and systemic embolism., DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized, multicenter trial (2000-2001) conducted at 409 North American sites, involving 3922 patients with nonvalvular atrial fibrillation and additional stroke risk factors., INTERVENTIONS: Adjusted-dose warfarin (aiming for an international normalized ratio [INR] 2.0 to 3.0) or fixed-dose oral ximelagatran, 36 mg twice daily., MAIN OUTCOME MEASURES: The primary end point was all strokes (ischemic or hemorrhagic) and systemic embolic events. The primary analysis was based on demonstrating noninferiority within an absolute margin of 2.0% per year according to the intention-to-treat model., RESULTS: During 6405 patient-years (mean 20 months) of follow-up, 88 patients experienced primary events. The mean (SD) INR with warfarin (2.4 [0.8]) was within target during 68% of the treatment period. The primary event rate with ximelagatran was 1.6% per year and with warfarin was 1.2% per year (absolute difference, 0.45% per year; 95% confidence interval, -0.13% to 1.03% per year; P

Author-supplied keywords

  • *Anticoagulants/tu [Therapeutic Use]
  • *Atrial Fibrillation/dt [Drug Therapy]
  • *Azetidines/tu [Therapeutic Use]
  • *Prodrugs/tu [Therapeutic Use]
  • *Stroke/pc [Prevention & Control]
  • *Warfarin/tu [Therapeutic Use]
  • Aged
  • Anticoagulants/ad [Administration & Dosage]
  • Anticoagulants/ae [Adverse Effects]
  • Atrial Fibrillation/co [Complications]
  • Azetidines/ad [Administration & Dosage]
  • Azetidines/ae [Adverse Effects]
  • Benzylamines
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Prodrugs/ad [Administration & Dosage]
  • Prodrugs/ae [Adverse Effects]
  • Stroke/et [Etiology]
  • Survival Analysis
  • Warfarin/ad [Administration & Dosage]
  • Warfarin/ae [Adverse Effects]

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Authors

  • Diener H C Albers GW Frison L, Grind M, Nevinson M, Partridge S, Halperin JL, Horrow J, Olsson SB, Petersen P, Vahanian A, SPORTIF Executive Steering Committee for the SPORTIF V Investigators

  • Gregory W Albers

  • Hans-Christoph Diener

  • Lars Frison

  • Margaretha Grind

  • Mark Nevinson

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