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
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)?
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 hemorrhageIntracerebral hemorrhage of any type in CT scans Death or disability by the alternative, but less widely used, shift analysis Death Disability 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
symptoms
- 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
agents.
- 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
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