Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)

PHASE3CompletedINTERVENTIONAL
Enrollment

4,587

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Ischemic StrokeHigh Blood Pressure
Interventions
DRUG

Low-dose rtPA

Patients allocated to low-dose will receive 0.6 mg/kg (maximum of 60 mg) i.v. (15% bolus \[maximum bolus dose of 9mg\] and 85% infusion over 60 mins) recombinant tissue plasminogen activator (rtPA).

DRUG

Standard-dose rtPA

Patients allocated to standard-dose will receive 0.9 mg/kg (maximum of 90 mg) i.v. (10% bolus and 90% infusion over 60 mins) rtPA.

OTHER

Intensive blood pressure (BP) lowering

"Intensive blood pressure (BP) lowering to a target systolic BP range 130-140 mmHg within one hour and to maintain this level for at least 72 hours (or until hospital discharge or death if this should occur earlier). A standardised i.v. BP lowering regimen using locally available and approved i.v. BP lowering agents will be used, commenced in the emergency department and later in a high dependency area (e.g. acute stroke or neurointensive care unit) as is usual for patients receiving rtPA.~The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."

OTHER

BP management policies

"Patients allocated to the control group will receive management of BP that is based on a standard guideline, as published by the AHA. For this group, the attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, i.v. treatment may be started until the target systolic BP of 180 mmHg is achieved.~The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."

Trial Locations (1)

2050

Royal Prince Alfred Hospital, Sydney

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Health and Medical Research Council, Australia

OTHER

collaborator

The Stroke Association, United Kingdom

OTHER

collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

collaborator

Takeda

INDUSTRY

lead

The George Institute

OTHER