ENCHANTED
Research type
Research Study
Full title
Enhanced Control of Hypertension and Thrombolysis Stroke Trial
IRAS ID
89284
Contact name
Thompson Robinson
Sponsor organisation
University of Leicester
Eudract number
2011-005545-12
ISRCTN Number
ISRCTN82387104
Clinicaltrials.gov Identifier
Research summary
Ischaemic stroke causes 9% of worldwide deaths, and is associated with very high health-care and socioeconomic costs. Recombinant tissue plasminogen activator (rtPA), a clot-busting drug, is the only approved treatment for acute ischaemic stroke (AIS), and studies suggest that low-dose rtPA is effective and associated with a reduced risk of symptomatic intracerebral haemorrhage (sICH) or bleeding into the brain, though there is a lack of trial evidence to support this. Furthermore, elevated blood pressure (BP) levels are common at stroke onset, and may be associated with poor outcome, including sICH complicating rtPA treatment. However, guidelines for managing high blood pressure in acute stroke are variable, though early intensive BP lowering may be of benefit. Therefore, ENCHANTED has been designed as an international, multicentre, randomised controlled trial to explore the effects of low- vs. standard-dose rtPA, and guideline vs. intensive BP lowering in AIS patients on outcome, in particular 3-month death and dependency and sICH rates. If the results of this trial are positive, it has the potential to increase independent outcome following stroke by a reduction in disabling rtPA-associated sICH.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
11/YH/0442
Date of REC Opinion
5 Jan 2012
REC opinion
Further Information Favourable Opinion