Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2×2 quasi-factorial randomized controlled trial of low- vs. standard-dose rt-PA and early intensive vs. g

Abstract

© 2015 World Stroke Organization. Rationale: Controversy exists over the optimal dose of intravenous (iv) recombinant tissue plasminogen activator (rt-PA) and degree of blood pressure (BP) control in acute ischaemic stroke (AIS). Asian studies suggest low-dose (0·6mg/kg) is more efficacious than standard-dose (0·9mg/kg) iv rt-PA, and guidelines recommend reducing systolic BP to <185mmHg before and <180mmHg after use of iv rt-PA, despite observational studies indicating better outcomes at much lower (<140mmHg) systolic BP levels in this patient group. Aims: The study aims to assess in thrombolysis-eligible AIS patients whether: (i) low-dose (0·6mg/kg body weight; maximum 60mg) iv rt-PA has non-inferior efficacy and lower risk of symptomatic intracerebral haemorrhage (sICH) compared to standard-dose (0·9mg/kg body weight; maximum 90mg) iv rt-PA; and (ii) early intensive BP lowering (systolic target 130-140mmHg) has superior efficacy and lower risk of any ICH compared to guideline-recomme