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

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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

  • *heart atrium fibrillation
  • *heart atrium fibrillation/dt [Drug Therapy]
  • *hospital patient
  • *prevention
  • *stroke
  • *stroke/dt [Drug Therapy]
  • *stroke/pc [Prevention]
  • *thrombosis prevention
  • *warfarin
  • *warfarin/ae [Adverse Drug Reaction]
  • *warfarin/cb [Drug Combination]
  • *warfarin/cm [Drug Comparison]
  • *warfarin/ct [Clinical Trial]
  • *warfarin/dt [Drug Therapy]
  • *ximelagatran
  • *ximelagatran/ae [Adverse Drug Reaction]
  • *ximelagatran/cb [Drug Combination]
  • *ximelagatran/cm [Drug Comparison]
  • *ximelagatran/ct [Clinical Trial]
  • *ximelagatran/dt [Drug Therapy]
  • *ximelagatran/po [Oral Drug Administration]
  • Kaplan Meier method
  • acetylsalicylic acid
  • acetylsalicylic acid/cb [Drug Combination]
  • acetylsalicylic acid/dt [Drug Therapy]
  • adult
  • age
  • aged
  • alanine aminotransferase
  • alanine aminotransferase blood level
  • alanine aminotransferase/ec [Endogenous Compound]
  • amiodarone
  • amiodarone/cb [Drug Combination]
  • amiodarone/dt [Drug Therapy]
  • anticoagulant therapy
  • antivitamin K
  • antivitamin K/cb [Drug Combination]
  • antivitamin K/dt [Drug Therapy]
  • article
  • beta adrenergic receptor blocking agent
  • beta adrenergic receptor blocking agent/cb [Drug C
  • beta adrenergic receptor blocking agent/dt [Drug T
  • bleeding
  • bleeding/si [Side Effect]
  • cardiovascular risk
  • cerebrovascular accident
  • cerebrovascular accident/dt [Drug Therapy]
  • cerebrovascular accident/pc [Prevention]
  • clinical trial
  • confidence interval
  • congestive heart failure
  • controlled clinical trial
  • controlled study
  • death
  • diabetes mellitus
  • diarrhea
  • diarrhea/si [Side Effect]
  • dipeptidyl carboxypeptidase inhibitor
  • dipeptidyl carboxypeptidase inhibitor/cb [Drug Com
  • dipeptidyl carboxypeptidase inhibitor/dt [Drug The
  • dizziness
  • dizziness/si [Side Effect]
  • double blind procedure
  • drug efficacy
  • edema
  • edema/si [Side Effect]
  • embolism
  • epistaxis
  • epistaxis/si [Side Effect]
  • fatigue
  • fatigue/si [Side Effect]
  • female
  • follow up
  • hematuria
  • hematuria/si [Side Effect]
  • human
  • hydroxymethylglutaryl coenzyme A reductase inhibit
  • hypertension
  • hypertension/dt [Drug Therapy]
  • hypothesis
  • international normalized ratio
  • liver disease
  • liver dysfunction
  • liver dysfunction/si [Side Effect]
  • liver toxicity
  • major clinical study
  • male
  • model
  • monitoring
  • mortality
  • multicenter study
  • nonsteroid antiinflammatory agent
  • nonsteroid antiinflammatory agent/cb [Drug Combina
  • patient
  • patient compliance
  • priority journal
  • purpura
  • purpura/si [Side Effect]
  • race
  • randomized controlled trial
  • risk factor
  • statistical analysis
  • thorax pain
  • thorax pain/si [Side Effect]
  • thrombin inhibitor
  • thrombin inhibitor/ae [Adverse Drug Reaction]
  • thrombin inhibitor/cb [Drug Combination]
  • thrombin inhibitor/cm [Drug Comparison]
  • thrombin inhibitor/ct [Clinical Trial]
  • thrombin inhibitor/dt [Drug Therapy]
  • thrombin inhibitor/po [Oral Drug Administration]
  • thromboembolism
  • thromboembolism/dt [Drug Therapy]
  • thromboembolism/pc [Prevention]
  • thrombosis prevention

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