Back to resultsEnhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) (ENCHANTED)
Primary Purpose
Ischemic Stroke, High Blood Pressure
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Low-dose rtPA
Standard-dose rtPA
Intensive blood pressure (BP) lowering
BP management policies
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Ischemic stroke, High blood pressure, Thrombolysis, Antihypertensive drugs, Disability, Clinical trial
Eligibility 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 (Recruitment completed in August 2015.):
- 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.
Sites / Locations
- Royal Prince Alfred Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Low-dose rtPA (Recruitment completed in August 2015)
Standard-dose rtPA (Recruitment completed in August 2015)
Early intensive BP lowering
Control / guideline-based BP management
Arm Description
low-dose 0.6 mg/kg (maximum of 60 mg) i.v. rtPA
standard-dose 0.9 mg/kg (maximum of 90 mg) i.v. rtPA
The trial is an assessment of BP lowering management strategies, using routinely available drugs. 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 (e.g. Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol Trinitrate, Phentolamine mesylate, Nicardipine, Urapidil, Esmolol, Clonidine, Enalaprilat, Nitroprusside) 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. Patients allocated to the control group will receive management of BP that is based on a standard guideline, as published by the American Heart Association (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.
Outcomes
Primary Outcome Measures
Combined death and disability
Unadjusted modified Rankin Scale [mRS] score 2-6
Secondary Outcome Measures
Symptomatic intracerebral hemorrhage
Brain imaging (or necropsy) confirmed ICH with deterioration in NIH Stroke Scale (NIHSS) score or death, as defined by the SITS-MOST criteria
Symptomatic intracerebral hemorrhage
Brain imaging (or necropsy) confirmed ICH with deterioration in NIH Stroke Scale (NIHSS) score or death, as defined by the NINDS trial criteria
Death or disability by the alternative, ordinal shift analysis
Unadjusted death or functional outcome by the alternative ordinal shift analysis of scores on the modified Rankin Scale [mRS]
Death
Death and 7 and 90 days
Disability
mRS score 2-5
Neurological deterioration
deterioration in NIHSS score
Health-related quality of life
Health-related quality of life by the EuroQoL
Admission to residential care
Health service use
Health service use for calculation of resources and costs
Symptomatic intracerebral hemorrhage (ICH)
By various other centrally adjudicated criteria, including ECASS2, ECASS3, IST-3 criteria, and fatal ICH within 7 days
Any intracerebral hemorrhage (ICH)
Centrally adjudicated review of brain imaging for any evidence of ICH
Death or disability in as treated per-protocol population
Adjusted death or functional outcome by the binary and alternative ordinal shift analysis of scores on the modified Rankin Scale [mRS]
Death or disability in as treated per-protocol population
Adjusted analysis of the modified Rankin Scale [mRS] score 2-6
Death or neurological deterioration
Death or neurological deterioration (defined by 4 points or more increase in NIHSS score from baseline)
Length of initial acute hospital stay
Length of hospital stay in days
Recurrent acute myocardial infarction and ischemic stroke
Recurrent acute myocardial infarction and ischemic stroke
Full Information
NCT ID
NCT01422616
First Posted
August 23, 2011
Last Updated
October 5, 2021
Sponsor
The George Institute
Collaborators
National Health and Medical Research Council, Australia, The Stroke Association, United Kingdom, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Takeda
1. Study Identification
Unique Protocol Identification Number
NCT01422616
Brief Title
Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)
Acronym
ENCHANTED
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 Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Institute
Collaborators
National Health and Medical Research Council, Australia, The Stroke Association, United Kingdom, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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-label, blinded endpoint (PROBE) controlled trial that involved 4587 patients (3310 for rtPA arm {recruitment completed in August 2015} and 2227 for BP arm {recruitment completed in April 2018} with 939 overlap) with acute ischaemic stroke recruited from over 100+ Clinical Centres from Australia, Asia, Europe and South America.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, High Blood Pressure
Keywords
Ischemic stroke, High blood pressure, Thrombolysis, Antihypertensive drugs, Disability, Clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4587 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose rtPA (Recruitment completed in August 2015)
Arm Type
Experimental
Arm Description
low-dose 0.6 mg/kg (maximum of 60 mg) i.v. rtPA
Arm Title
Standard-dose rtPA (Recruitment completed in August 2015)
Arm Type
Active Comparator
Arm Description
standard-dose 0.9 mg/kg (maximum of 90 mg) i.v. rtPA
Arm Title
Early intensive BP lowering
Arm Type
Experimental
Arm Description
The trial is an assessment of BP lowering management strategies, using routinely available drugs.
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 (e.g. Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol Trinitrate, Phentolamine mesylate, Nicardipine, Urapidil, Esmolol, Clonidine, Enalaprilat, Nitroprusside) 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.
Arm Title
Control / guideline-based BP management
Arm Type
Active Comparator
Arm Description
The trial is an assessment of BP lowering management strategies, using routinely available drugs.
Patients allocated to the control group will receive management of BP that is based on a standard guideline, as published by the American Heart Association (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.
Intervention Type
Drug
Intervention Name(s)
Low-dose rtPA
Other Intervention Name(s)
Actilyse
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Standard-dose rtPA
Other Intervention Name(s)
Actilyse
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intensive blood pressure (BP) lowering
Other Intervention Name(s)
Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol Trinitrate, Phentolamine mesylate, Nicardipine, Urapidil, Esmolol, Clonidine, Enalaprilat, Niroprusside
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
BP management policies
Other Intervention Name(s)
Labetalol Hydrochloride, Metoprolol tartrate, Hydralazine Hydrochloride, Glycerol Trinitrate, Phentolamine mesylate, Nicardipine, Urapidil, Esmolol, Clonidine, Enalaprilat, Niroprusside
Intervention Description
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.
Primary Outcome Measure Information:
Title
Combined death and disability
Description
Unadjusted modified Rankin Scale [mRS] score 2-6
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Symptomatic intracerebral hemorrhage
Description
Brain imaging (or necropsy) confirmed ICH with deterioration in NIH Stroke Scale (NIHSS) score or death, as defined by the SITS-MOST criteria
Time Frame
36 hours
Title
Symptomatic intracerebral hemorrhage
Description
Brain imaging (or necropsy) confirmed ICH with deterioration in NIH Stroke Scale (NIHSS) score or death, as defined by the NINDS trial criteria
Time Frame
36 hours
Title
Death or disability by the alternative, ordinal shift analysis
Description
Unadjusted death or functional outcome by the alternative ordinal shift analysis of scores on the modified Rankin Scale [mRS]
Time Frame
90 days
Title
Death
Description
Death and 7 and 90 days
Time Frame
at 7 and 90 days
Title
Disability
Description
mRS score 2-5
Time Frame
90 days
Title
Neurological deterioration
Description
deterioration in NIHSS score
Time Frame
72 hours
Title
Health-related quality of life
Description
Health-related quality of life by the EuroQoL
Time Frame
90 days
Title
Admission to residential care
Time Frame
90 days
Title
Health service use
Description
Health service use for calculation of resources and costs
Time Frame
90 days
Title
Symptomatic intracerebral hemorrhage (ICH)
Description
By various other centrally adjudicated criteria, including ECASS2, ECASS3, IST-3 criteria, and fatal ICH within 7 days
Time Frame
within 7 days
Title
Any intracerebral hemorrhage (ICH)
Description
Centrally adjudicated review of brain imaging for any evidence of ICH
Time Frame
any time during 90 days
Title
Death or disability in as treated per-protocol population
Description
Adjusted death or functional outcome by the binary and alternative ordinal shift analysis of scores on the modified Rankin Scale [mRS]
Time Frame
90 days
Title
Death or disability in as treated per-protocol population
Description
Adjusted analysis of the modified Rankin Scale [mRS] score 2-6
Time Frame
90 days
Title
Death or neurological deterioration
Description
Death or neurological deterioration (defined by 4 points or more increase in NIHSS score from baseline)
Time Frame
72 hours
Title
Length of initial acute hospital stay
Description
Length of hospital stay in days
Time Frame
within 90 days
Title
Recurrent acute myocardial infarction and ischemic stroke
Description
Recurrent acute myocardial infarction and ischemic stroke
Time Frame
within 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 (Recruitment completed in August 2015.):
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig S Anderson, MD
Organizational Affiliation
The George Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing upon approval through formal application to the Research Office of The George Institute for Global Health, Australia
IPD Sharing Time Frame
available
IPD Sharing Access Criteria
approved protocol, ethics committee and data sharing agreement
Citations:
PubMed Identifier
26283139
Citation
Anderson CS, Woodward M, Arima H, Chen X, Lindley RI, Wang X, Chalmers J; ENCHANTED Investigators. Statistical analysis plan for evaluating low- vs. standard-dose alteplase in the ENhanced Control of Hypertension and Thrombolysis strokE stuDy (ENCHANTED). Int J Stroke. 2015 Dec;10(8):1313-5. doi: 10.1111/ijs.12602. Epub 2015 Aug 18.
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29777016
Citation
Nagel S, Wang X, Carcel C, Robinson T, Lindley RI, Chalmers J, Anderson CS; ENCHANTED Investigators. Clinical Utility of Electronic Alberta Stroke Program Early Computed Tomography Score Software in the ENCHANTED Trial Database. Stroke. 2018 Jun;49(6):1407-1411. doi: 10.1161/STROKEAHA.117.019863. Epub 2018 May 18.
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PubMed Identifier
29571842
Citation
Chen G, Wang X, Robinson TG, Pikkemaat M, Lindley RI, Zhou S, Ping L, Liu W, Liu L, Chalmers J, Anderson CS; ENCHANTED Investigators. Comparative effects of low-dose versus standard-dose alteplase in ischemic patients with prior stroke and/or diabetes mellitus: The ENCHANTED trial. J Neurol Sci. 2018 Apr 15;387:1-5. doi: 10.1016/j.jns.2018.01.014. Epub 2018 Jan 11.
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PubMed Identifier
29402064
Citation
Kim JS, Kim YJ, Lee KB, Cha JK, Park JM, Hwang Y, Kim EG, Rha JH, Koo J, Kim J, Kim YJ, Seo WK, Kim DE, Robinson TG, Lindley RI, Wang X, Chalmers J, Anderson CS. Low- versus Standard-Dose Intravenous Alteplase in the Context of Bridging Therapy for Acute Ischemic Stroke: A Korean ENCHANTED Study. J Stroke. 2018 Jan;20(1):131-139. doi: 10.5853/jos.2017.01578. Epub 2018 Jan 31.
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PubMed Identifier
29185557
Citation
Xu Y, Hackett ML, Chalmers J, Lindley RI, Wang X, Li Q, Robinson T, Arima H, Lavados PM, Anderson CS; ENCHANTED Study Group. Frequency, determinants, and effects of early seizures after thrombolysis for acute ischemic stroke: The ENCHANTED trial. Neurol Clin Pract. 2017 Aug;7(4):324-332. doi: 10.1212/CPJ.0000000000000384.
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PubMed Identifier
28973174
Citation
Wang X, Robinson TG, Lee TH, Li Q, Arima H, Bath PM, Billot L, Broderick J, Demchuk AM, Donnan G, Kim JS, Lavados P, Lindley RI, Martins SO, Olavarria VV, Pandian JD, Parsons MW, Pontes-Neto OM, Ricci S, Sharma VK, Thang NH, Wang JG, Woodward M, Anderson CS, Chalmers J; Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) Investigators. Low-Dose vs Standard-Dose Alteplase for Patients With Acute Ischemic Stroke: Secondary Analysis of the ENCHANTED Randomized Clinical Trial. JAMA Neurol. 2017 Nov 1;74(11):1328-1335. doi: 10.1001/jamaneurol.2017.2286. Erratum In: JAMA Neurol. 2018 Mar 1;75(3):384.
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PubMed Identifier
28739832
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Carr SJ, Wang X, Olavarria VV, Lavados PM, Rodriguez JA, Kim JS, Lee TH, Lindley RI, Pontes-Neto OM, Ricci S, Sato S, Sharma VK, Woodward M, Chalmers J, Anderson CS, Robinson TG; ENCHANTED Investigators. Influence of Renal Impairment on Outcome for Thrombolysis-Treated Acute Ischemic Stroke: ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study) Post Hoc Analysis. Stroke. 2017 Sep;48(9):2605-2609. doi: 10.1161/STROKEAHA.117.017808. Epub 2017 Jul 24.
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PubMed Identifier
28619989
Citation
Robinson TG, Wang X, Arima H, Bath PM, Billot L, Broderick JP, Demchuk AM, Donnan GA, Kim JS, Lavados PM, Lee TH, Lindley RI, Martins SCO, Olavarria VV, Pandian JD, Parsons MW, Pontes-Neto OM, Ricci S, Sato S, Sharma VK, Nguyen TH, Wang JG, Woodward M, Chalmers J, Anderson CS; ENCHANTED Investigators. Low- Versus Standard-Dose Alteplase in Patients on Prior Antiplatelet Therapy: The ENCHANTED Trial (Enhanced Control of Hypertension and Thrombolysis Stroke Study). Stroke. 2017 Jul;48(7):1877-1883. doi: 10.1161/STROKEAHA.116.016274. Epub 2017 Jun 15.
Results Reference
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Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)
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