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Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2x2 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
Huang, Yining1; Sharma, Vijay K.2,3; Robinson, Thompson4,5; Lindley, Richard I.6,7; Chen, Xiaoying6,7; Kim, Jong Sung8; Lavados, Pablo9,10; Olavarria, Veronica9; Arima, Hisatomi6,7; Fuentes, Sully6,7; Huy Thang Nguyen11; Lee, Tsong-Hai12; Parsons, Mark W.13; Levi, Christopher13; Demchuk, Andrew M.14; Bath, Philip M. W.15; Broderick, Joseph P.16,17; Donnan, Geoffrey A.18; Martins, Sheila19; Pontes-Neto, Octavio M.20; Silva, Federico21; Pandian, Jeyaraj22; Ricci, Stefano23; Stapf, Christian24,25; Woodward, Mark6,7; Wang, Jiguang26; Chalmers, John6,7; Anderson, Craig S.6,7; ENCHANTED Investigators
关键词acute ischaemic stroke Alteplase dose hypertension rt-PA thrombolysis
刊名INTERNATIONAL JOURNAL OF STROKE
2015-07-01
DOI10.1111/ijs.12486
10期:5页:778-788
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Peripheral Vascular Disease
研究领域[WOS]Cardiovascular System & Cardiology
关键词[WOS]TISSUE-PLASMINOGEN-ACTIVATOR ; INTRAVENOUS THROMBOLYSIS ; SAFE IMPLEMENTATION ; URGENT THERAPY ; 0.6 MG/KG ; ALTEPLASE ; JAPANESE ; METAANALYSIS ; ASSOCIATION ; HEMORRHAGE
英文摘要

RationaleControversy 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 (06mg/kg) is more efficacious than standard-dose (09mg/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.

AimsThe study aims to assess in thrombolysis-eligible AIS patients whether: (i) low-dose (06mg/kg body weight; maximum 60mg) iv rt-PA has non-inferior efficacy and lower risk of symptomatic intracerebral haemorrhage (sICH) compared to standard-dose (09mg/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-recommended BP control (systolic target<180mmHg).

DesignThe ENhanced Control of Hypertension And Thrombolysis strokE stuDy (ENCHANTED) trial is an independent,2x2 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 outcomesThe 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.

ResultsFollowing 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 iv rt-PA and superiority of intensive BP lowering on the primary clinical outcome, respectively.

ConclusionsLow-dose iv rt-PA and early intensive BP lowering could provide more affordable and safer use of thrombolysis treatment for patients with AIS worldwide.

语种英语
WOS记录号WOS:000356718000035
项目编号1020462 ; TSA 2012/01 ; 467322/2014-7
资助机构National Health and Medical Research Council (NHMRC) of Australia ; Stroke Association of United Kingdom ; National Council for Scientific and Technological Development of Brazil (CNPq)
引用统计
被引频次:31[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/63949
专题北京大学第一临床医学院_神经内科
作者单位1.USL Umbria 1, UO Neurol, Umbria, Italy
2.Linkou Chang Gung Mem Hosp, Taoyuan, Taiwan
3.Florey Inst Neurosci & Mental Hlth, Parkville, Vic, Australia
4.Fdn Cardiovasc, Bucaramanga, Colombia
5.Peking Univ, Hosp 1, Dept Neurol, Beijing 100871, Peoples R China
6.Natl Univ Singapore, Natl Univ Hosp, Dept Med, Div Neurol, Singapore 117548, Singapore
7.Natl Univ Singapore, YLL Sch Med, Singapore 117548, Singapore
8.Univ Leicester Univ, Dept Cardiovasc Sci, Leicester, Leics, England
9.Univ Leicester Univ, NIHR Biomed Res Unit, Leicester, Leics, England
10.Royal Prince Alfred Hosp, George Inst Global Hlth, Sydney, NSW, Australia
11.Univ Sydney, Sydney, NSW 2006, Australia
12.Univ Ulsan, Asan Med Ctr, Seoul, South Korea
13.Univ Chile, Santiago, Chile
14.Peoples 115 Hosp, Stroke Unit, Ho Chi Minh City, Vietnam
15.Univ Desarrollo, Clin Alemana Santiago, Santiago, Chile
16.Univ Newcastle, John Hunter Hosp, Hunter Med Res Inst, Newcastle, NSW 2300, Australia
17.Univ Calgary, Dept Clin Neurosci & Radiol, Hotchkiss Brain Inst, Calgary Stroke Program, Calgary, AB, Canada
18.Univ Nottingham, Div Clin Neurosci, Stroke Trials Unit, Nottingham NG7 2RD, England
19.Univ Cincinnati, Acad Hlth Ctr, Dept Neurol & Rehabil Med, Neurosci Inst, Cincinnati, OH USA
20.Univ Cincinnati, Acad Hlth Ctr, Dept Radiol, Neurosci Inst, Cincinnati, OH USA
21.Univ Fed Rio Grande do Sul, Hosp Clin Porto Alegre, BR-90046900 Porto Alegre, RS, Brazil
22.Univ Sao Paulo, Ribeirao Preto Sch Med, Dept Neurosci & Behav, Stroke Serv,Neurol Div, BR-14049 Ribeirao Preto, SP, Brazil
23.Christian Med Coll & Hosp, Dept Neurol, Ludhiana, Punjab, India
24.Univ Paris Diderot, Sorbonne Paris Cite, Hop Lariboisiere, APHP,Dept Neurol, Paris, France
25.Univ Paris Diderot, Sorbonne Paris Cite, DHU NeuroVasc Paris Sorbonne, Paris, France
26.Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Shanghai Inst Hypertens, Shanghai 200030, Peoples R China
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Huang, Yining,Sharma, Vijay K.,Robinson, Thompson,et al. Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2x2 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[J]. INTERNATIONAL JOURNAL OF STROKE,2015,10(5):778-788.
APA Huang, Yining.,Sharma, Vijay K..,Robinson, Thompson.,Lindley, Richard I..,Chen, Xiaoying.,...&ENCHANTED Investigators.(2015).Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2x2 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.INTERNATIONAL JOURNAL OF STROKE,10(5),778-788.
MLA Huang, Yining,et al."Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2x2 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".INTERNATIONAL JOURNAL OF STROKE 10.5(2015):778-788.
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