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. guideline-recommended blood pressure lowering in patients with acute ischaemic stroke eligible for thrombolysis treatment

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dc.contributor.authorHuang, Yining
dc.contributor.authorSharma, Vijay
dc.contributor.authorRobinson, Thompson
dc.contributor.authorLindley, Richard
dc.contributor.authorChen, Xiaoying
dc.contributor.authorKim, Jong Sung
dc.contributor.authorLavados, Pablo
dc.contributor.authorOlavarría, Verónica
dc.contributor.authorArima, Hisatomi
dc.contributor.authorFuentes, Sully
dc.contributor.authorNguyen, Huy Thang
dc.contributor.authorLee, Tsong-Hai
dc.contributor.authorParsons, Mark
dc.contributor.authorLevi, Christopher
dc.contributor.authorDemchuk, Andrew
dc.contributor.authorBath, Philip
dc.contributor.authorBroderick, Joseph
dc.contributor.authorDonnan, Geoffrey
dc.contributor.authorMartins, Sheila
dc.contributor.authorPontes-Neto, Octavio
dc.contributor.authorSilva, Federico
dc.contributor.authorPandian, Jeyaraj
dc.contributor.authorRicci, Stefano
dc.contributor.authorStapf, Christian
dc.contributor.authorWoodward, Mark
dc.contributor.authorWang, Jiguang
dc.contributor.authorChalmers, John
dc.contributor.authorAnderson, Craig
dc.date.accessioned2017-05-04T20:00:32Z
dc.date.available2017-05-04T20:00:32Z
dc.date.issued2015
dc.description.abstractRATIONALE: Controversy exists over the optimal dose of intravenous (i.v.) recombinant tissue plasminogen activator (rt-PA) and degree of blood pressure (BP) control in acute ischaemic stroke (AIS). Asian studies suggest low-dose (0·6 mg/kg) is more efficacious than standard-dose (0·9 mg/kg) i.v. rt-PA, and guidelines recommend reducing systolic BP to <185 mmHg before and <180 mmHg after use of i.v. rt-PA, despite observational studies indicating better outcomes at much lower (<140 mmHg) systolic BP levels in this patient group. AIMS: The study aims to assess in thrombolysis-eligible AIS patients whether: (i) low-dose (0·6 mg/kg body weight; maximum 60 mg) i.v. rt-PA has non-inferior efficacy and lower risk of symptomatic intracerebral haemorrhage (sICH) compared to standard-dose (0·9 mg/kg body weight; maximum 90 mg) i.v. rt-PA; and (ii) early intensive BP lowering (systolic target 130-140 mmHg) has superior efficacy and lower risk of any ICH compared to guideline-recommended BP control (systolic target < 180 mmHg). DESIGN: The ENhanced Control of Hypertension And Thrombolysis strokE stuDy (ENCHANTED) trial is an independent,2 × 2 quasi-factorial, active-comparison, prospective, randomized, open blinded endpoint (PROBE), clinical trial that is evaluating Arm [A] 'rt-PA dose' and/or Arm [B] 'BP control', using central Internet randomization and data collection in patients fulfilling local criteria for thrombolysis and clinician uncertainty over the study treatments. The treatment arms will be analyzed separately. STUDY OUTCOMES: The primary study outcome in both trial Arms is death or disability according to the modified Rankin scale (mRS, scores 2-6) assessed at 90 days. Secondary outcomes include sICH, any ICH, a shift ('improvement') in function across mRS scores, separately on death and disability, early neurological deterioration, recurrent major vascular events, health-related quality of life, length of hospital stay, need for permanent residential care, and health care costs. RESULTS: Following launch of the trial in February 2012, the study has recruited more than 2500 patients across a global network of approximately 100 sites in 15 countries. The required sample sizes are 3300 for Arm [A] and 2300 for Arm [B], which will provide >90% power to detect non-inferiority of low-dose i.v. rt-PA and superiority of intensive BP lowering on the primary clinical outcome, respectively. CONCLUSIONS: Low-dose i.v. rt-PA and early intensive BP lowering could provide more affordable and safer use of thrombolysis treatment for patients with AIS worldwide.
dc.format.extent11
dc.identifier.citationInt J Stroke. 2015 Jul;10(5):778-788
dc.identifier.urihttp://hdl.handle.net/11447/1195
dc.identifier.urihttp://dx.doi.org/10.1111/ijs.12486
dc.language.isoen_US
dc.publisherSage Publications
dc.subjectAlteplase
dc.subjectAcute ischaemic stroke
dc.subjectDose
dc.subjectHypertension
dc.subjectRt-PA
dc.subjectThrombolysis
dc.titleRationale, 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. guideline-recommended blood pressure lowering in patients with acute ischaemic stroke eligible for thrombolysis treatment
dc.typeArtículo

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