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randomised, placebo-controlled trial. ClinicalTrials.gov NCT00143715.
blinded (patients, clinicians, research coordinators, and outcome adjudicators).*
14 anticoagulant centres in the USA, Canada, and Italy.
724 outpatients ⩾18 years of age (mean age 69 y, 53% men) who attended clinic for routine international normalised ratio (INR) assessment, were receiving warfarin with a target INR of 2.0–3.5, were not bleeding, and had an INR between 4.5 and 10.0 in the past 24 hours. Exclusion criteria included life expectancy <10 days, indication for acute normalisation of INR, scheduled discontinuation of warfarin, known bleeding disorder, recent major bleeding, inability to take oral medication or undergo follow-up, contraindication to vitamin K, severe liver disease, thrombolytic therapy within 48 hours, and …
Source of funding: Canadian Institutes of Health Research and Italian Ministry of Universities and Research.