Huang, Yining; Sharma, Vijay K; Robinson, Thompson; Lindley, Richard I; Chen, Xiaoying; Kim, Jong Sung; Lavados, Pablo; Olavarria, Veronica; Arima, Hisatomi; Fuentes, Sully; Nguyen, Huy Thang; Lee, Tsong-Hai; Parsons, Mark W; Levi, Christopher; Demchuk, Andrew M; Bath, Philip M W; Broderick, Joseph P; Donnan, Geoffrey A; Martins, Sheila; Pontes-Neto, Octavio M; Silva, Federico; Pandian, Jeyaraj; Ricci, Stefano; Stapf, Christian; Woodward, Mark; Wang, Jiguang; Chalmers, John; Anderson, Craig S
International journal of stroke : official journal of the International Stroke Society
2015Jul ; 10 ( 5 ) :778-88.
PMID : 25832995
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Huang, Yining -
Sharma, Vijay K -
Robinson, Thompson -
Lindley, Richard I -
Chen, Xiaoying -
Kim, Jong Sung -
Lavados, Pablo -
Olavarria, Veronica -
Arima, Hisatomi -
Fuentes, Sully -
Nguyen, Huy Thang -
Lee, Tsong-Hai -
Parsons, Mark W -
Levi, Christopher -
Demchuk, Andrew M -
Bath, Philip M W -
Broderick, Joseph P -
Donnan, Geoffrey A -
Martins, Sheila -
Pontes-Neto, Octavio M -
Silva, Federico -
Pandian, Jeyaraj -
Ricci, Stefano -
Stapf, Christian -
Woodward, Mark -
Wang, Jiguang -
Chalmers, John -
Anderson, Craig S -
ABSTRACT
RATIONALE: 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?
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. CI - ??2015 World Stroke Organization.
keyword
Alteplase; acute ischaemic stroke; dose; hypertension; rt-PA; thrombolysis
MESH
Brain Ischemia/complications, Female, Fibrinolytic Agents/*therapeutic use, Humans, *International Cooperation, Male, Stroke/*drug therapy/etiology, Tissue Plasminogen Activator/*therapeutic use, Treatment Outcome
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