Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
ENCHANTED is an independent, investigator initiated, international collaborative,
quasi-factorial randomised controlled trial involving a package of 2 linked comparative
randomised treatment arms, which aims to address 4 key questions in patients eligible for
thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg)
intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent
benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP)
lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline
recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg)
intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of
symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering
to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?
The rtPA dose arm of the study addressing questions (1) and (3) concluded with a publication
of the results in May 2016. The BP intensity arm of the study addressing questions (2) and
(4) concluded with a publication of the results in February 2019.
Phase:
Phase 3
Details
Lead Sponsor:
The George Institute
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico Ministry for Health, Welfare and Family Affairs of the Republic of Korea National Health and Medical Research Council, Australia Takeda Takeda China (for the BP lowering arm of the study in China, from March 2016) The Stroke Association, United Kingdom