1. Dabigatran Treatment of Acute Non-Cardioembolic Ischaemic Stroke: A Randomised Controlled Trial
- Author
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Patrick Sheridan, Shelagh B. Coutts, Jodi Miller, Laura C. Gioia, Mike Sharma, Kenneth Butcher, Ana C Klahr, Michael D. Hill, Kelvin Tsun Wai Ng, Muzzafar Siddiqui, Oscar R. Benavente, Brian Buck, Thalia S. Field, Robert G. Hart, and Leka Sivakumar
- Subjects
medicine.medical_specialty ,Aspirin ,business.industry ,Warfarin ,Atrial fibrillation ,medicine.disease ,Asymptomatic ,law.invention ,Dabigatran ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,medicine.symptom ,business ,Stroke ,medicine.drug - Abstract
Background: Transient ischaemic attack (TIA) and minor ischaemic stroke patients are at high risk for recurrent events. Anticoagulants are associated with reduced recurrent ischemic stroke rates, but also increased risk of haemorrhagic transformation (HT). Dabigatran, a novel oral anticoagulant associated with reduced risk of intracranial bleeding compared with warfarin in atrial fibrillation patients, has not been assessed in acute brain ischemia. We hypothesised that HT rates are not increased by dabigatran relative to aspirin after acute ischaemic stroke/TIA. Methods: DAbigatran Treatment of Acute Stroke II (DATAS II) was a prospective, randomised open label, blinded endpoint trial of dabigatran versus aspirin in acute stroke/TIA (clinicatrials.gov NCT02295826). Non-cardio-embolic stroke/TIA patients (NIHSS score ≤9, infarct volume < 25 ml) who did not receive thrombolytic therapy or thrombectomy were randomised 1:1 to dabigatran 150 mg BID (110 mg BID in patients ≥80 or if CrCl
- Published
- 2019