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Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)

Information source: The George Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemic Stroke; High Blood Pressure

Intervention: Low-dose rtPA (Drug); Standard-dose rtPA (Drug); Intensive blood pressure (BP) lowering (Other); BP management policies (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: The George Institute

Official(s) and/or principal investigator(s):
Craig S Anderson, MD, Principal Investigator, Affiliation: The George Institute

Overall contact:
Craig Anderson, MD, Phone: +61 2 9993 4500, Email: canderson@georgeinstitute.org.au


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)?

Clinical Details

Official title: An International Randomised Controlled Trial to Establish the Effects of Low-dose rtPA and the Effects of Early Intensive Blood Pressure Lowering in Patients With Acute Ischaemic Stroke

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Combined death and any disability

Secondary outcome:

Symptomatic intracerebral hemorrhage

Intracerebral hemorrhage of any type in CT scans

Death or disability by the alternative, but less widely used, shift analysis



Neurological deterioration

Health-related quality of life

Admission to residential care

Health service use

Detailed description: This study is an international, multicentre, prospective, fixed-time point (optional) randomisation for two arms ([A] 'dose of rtPA' and [B] 'level of BP control'), open, blinded endpoint (PROBE), controlled trial that will involve over 4800 patients (3300 for rtPA arm and 2304 for BP arm with 800 overlap) with acute ischaemic stroke recruited from over 100+ Clinical Centres from Australia, Asia, Europe and South America.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adult (age ≥18 years)

- A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging

- Able to receive treatment within 4. 5 hours after the definite time of onset of


- Have a systolic BP ≤185 mmHg

- Provide informed consent (or via an appropriate proxy, according to local

requirements) Specific criteria for arm [A] of low-dose vs standard-dose rtPA:

- Able to receive either low-dose or standard-dose rtPA

Specific criteria for arm [B] of intensive BP lowering vs guideline recommended BP control

- Patient will or has received thrombolysis treatment with rtPA, either randomised dose

within the trial or physician decided dose rtPA outside of the trial

- Sustained elevated systolic BP level, defined as 2 readings 150 mmHg

- Able to commence intensive BP lowering treatment within 6 hours of stroke onset

- Able to receive either immediate intensive BP lowering or conservative BP management

Exclusion Criteria:

- Unlikely to potentially benefit from the therapy (e. g. advanced dementia), or a very

high likelihood of death within 24 hours of stroke onset.

- Other medical illness that interferes with outcome assessments and follow-up [known

significant pre-stroke disability (mRS scores 2-5)].

- Specific contraindications to rtPA (Actilyse) or any of the blood pressure agents to

be used.

- Participation in another clinical trial involving evaluation of pharmacological


- Need for following concomitant medication, including phosphodiesterase inhibitors and

monoamine oxidase inhibitors.

Locations and Contacts

Craig Anderson, MD, Phone: +61 2 9993 4500, Email: canderson@georgeinstitute.org.au

Royal Prince Alfred Hospital, Sydney, New South Wales 2050, Australia; Recruiting
Craig S Anderson, MD, Phone: +61 2 933 4500, Email: canderson@georgeinstitute.org.au
Additional Information

Starting date: March 2012
Last updated: March 11, 2015

Page last updated: August 23, 2015

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