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    Clinical Trial Results:
    Enhanced Control of Hypertension and Thrombolysis Stroke Trial

    Summary
    EudraCT number
    		 2011-005545-12
    Trial protocol
    		 GB  
    Global end of trial date
    02 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jan 2020
    First version publication date
    02 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    0250
    Additional study identifiers
    ISRCTN number
    		 ISRCTN82387104
    US NCT number
    		 NCT01422616
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The University of Leicester
    Sponsor organisation address
    University Road, Leicester, United Kingdom, LE1 7RH
    Public contact
    Professor T G Robinson, University of Leicester, +44 01162523182, tgr2@le.ac.uk
    Scientific contact
    Professor T G Robinson, University of Leicester, +44 01162523182, tgr2@le.ac.uk
    Sponsor organisation name
    University of Leicester
    Sponsor organisation address
    University Road, Leicester, United Kingdom, LE1 7RH
    Public contact
    Prof Thompson Robinson, University of Leicester, +44 0116 252 2962, tgr2@le.ac.uk
    Scientific contact
    Prof Thompson Robinson, University of Leicester, +44 0116 252 2962, tgr2@le.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Oct 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall objective is to increase the number of acute ischaemic stroke patients eligible for thrombolysis (clot-busting treatment), and to improve thrombolysis outcomes by reducing rates of bleeding into the brain (symptomatic intracerebral haemorrhage, sICH). Therefore, the principal aims are to determine: [A] whether compared to the standard dose, low-dose rtPA is at least as effective (‘not inferior’) on death or any disability; [B] whether compared with current guideline recommended criteria for BP management, early intensive BP lowering is superior in reducing the risk of death or any disability.
    Protection of trial subjects
    Exclusion criteria applied regarding contra-indication to the investigation product.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 970
    Country: Number of subjects enrolled
    Australia: 59
    Country: Number of subjects enrolled
    Brazil: 254
    Country: Number of subjects enrolled
    Chile: 136
    Country: Number of subjects enrolled
    China: 2196
    Country: Number of subjects enrolled
    Colombia: 13
    Country: Number of subjects enrolled
    Hong Kong: 7
    Country: Number of subjects enrolled
    India: 35
    Country: Number of subjects enrolled
    Italy: 65
    Country: Number of subjects enrolled
    Korea, Republic of: 362
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Singapore: 33
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Taiwan: 62
    Country: Number of subjects enrolled
    Thailand: 2
    Country: Number of subjects enrolled
    Vietnam: 357
    Worldwide total number of subjects
    4557
    EEA total number of subjects
    1041
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1950
    From 65 to 84 years
    2310
    85 years and over
    297

    Subject disposition

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    Recruitment
    Recruitment details
    		 Low dose n= 1654 Standard dose n= 1643 Intensive BP lowering n= 1081 Standard BP lowering n= 1115 Total Recruited n=4597 First patient in date= 3 March 2012 / last patient in date = 30 April 2018

    Pre-assignment
    Screening details
    		 Patients were screen by Clinical Research Teams on stroke units at the beginning of shifts to assess eligibility for ENCHANTED. If an eligible patient was identified, the delegated medic would approach to discuss the information sheet with patient and family/legal representatives before moving to consent.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Assessor, Subject
    Blinding implementation details
    The 28 and 90 day evaluations will be conducted in-person or by telephone, by a trained staff member at the local site who is blind to the treatment allocation.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Low Dose Alteplase
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Alteplase
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use , Intravenous drip use
    Dosage and administration details
    0.6mg/kg

    Arm title
    		 Standard Dose Alteplase
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Alteplase
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use , Intravenous drip use
    Dosage and administration details
    0.9mg/kg

    Arm title
    		 Intensive Blood Pressure Lowering
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    transdermal glyceryl trinitrate
    Investigational medicinal product code
    Other name
    Deponit 5
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Maximum cumulative Deponit dose to be received by participants in the ENCHANTED trial is 10mg per day.

    Arm title
    		 Standard Blood Pressure Lowering
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    transdermal glyceryl trinitrate
    Investigational medicinal product code
    Other name
    Deponit 5
    Pharmaceutical forms
    Transdermal patch
    Routes of administration
    Transdermal use
    Dosage and administration details
    Maximum cumulative Deponit dose to be received by participants in the ENCHANTED trial is 10mg per day.

    Number of subjects in period 1
    		Low Dose Alteplase Standard Dose Alteplase Intensive Blood Pressure Lowering Standard Blood Pressure Lowering
    Started
    1607
    1599
    1072
    1108
    Completed
    1607
    1599
    1072
    1108

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 4557 4557
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 1950 1950
        From 65-84 years
    		 2310 2310
        85 years and over
    		 297 297
    Gender categorical
    Units: Subjects
        Female
    		 1722 1722
        Male
    		 2835 2835

    End points

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    End points reporting groups
    Reporting group title
    Low Dose Alteplase
    Reporting group description
    		 -

    Reporting group title
    Standard Dose Alteplase
    Reporting group description
    		 -

    Reporting group title
    Intensive Blood Pressure Lowering
    Reporting group description
    		 -

    Reporting group title
    Standard Blood Pressure Lowering
    Reporting group description
    		 -

    Subject analysis set title
    Low dose alteplase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    low dose alteplase 0.6mg/kg

    Subject analysis set title
    Standard dose alteplase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Standard-dose arm 0.9mg/kg

    Subject analysis set title
    Intensive BP Lowering
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intensive BP lowering, target <140mmHg systolic

    Subject analysis set title
    Standard BP Lowering
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Target lowering BP to <180mmHg systolic

    Primary: mRS at Day 90 in BP arms

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    End point title
    		 mRS at Day 90 in BP arms
    End point description
    Primary outcome data were available for 1072 patients in the intensive group and 1108 in the guideline group. Functional status (mRS score distribution) at 90 days did not differ between groups (unadjusted odds ratio [OR] 1·01, 95% CI 0·87–1·17, p=0·870)
    End point type
    Primary
    End point timeframe
    Randomisation to Day 90
    End point values
    		 Low Dose Alteplase Standard Dose Alteplase Intensive Blood Pressure Lowering Standard Blood Pressure Lowering Low dose alteplase Standard dose alteplase Intensive BP Lowering Standard BP Lowering
    Number of subjects analysed
    1607
    1599
    1072
    1108
    Units: Scale
        number (confidence interval 95%)
    1.05 (0.90 to 1.22)
    1.05 (0.90 to 1.22)
    1.01 (0.87 to 1.17)
    1.01 (0.87 to 1.17)
    1.05 (0.90 to 1.22)
    1.05 (0.9 to 1.22)
    1.01 (0.87 to 1.17)
    1.01 (0.87 to 1.17)
    Statistical analysis title
    		 Ordinal Shift Analysis
    Statistical analysis description
    Power calculations were based on the estimated treatment effects on a conventional binary assessment of poor outcome (mRS scores 3–6). Assuming poor outcomes of 43% in the intensive blood pressure lowering group and 50% in the guideline-recommended blood pressure lowering group, a sample size of 2304 (1152 per group) was estimated to provide more than 90% power (using a two-sided α=0·05) to detect a 14% relative reduction in poor outcome in the intensive group.
    Comparison groups
    Intensive Blood Pressure Lowering v Standard Blood Pressure Lowering
    Number of subjects included in analysis
    2180
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.87
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [1] - Statistical analyses were done on an intention-to-treat basis. We did shift analyses using ordinal logistic regression for the primary efficacy outcome, and dichotomous logistic regression analyses for all other outcomes.All tests were two-sided and the nominal level of α was 5%.

    Primary: mRS at Day 90 in dose arms

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    End point title
    		 mRS at Day 90 in dose arms
    End point description
    No significant differences in the treatment effects were observed between low- and standard-dose alteplase for poor outcomes (death or disability) by age, ethnicity, or severity (all P > .37 for interaction). Similarly, the treatment effects of low-vs standard-dose alteplase on function outcome (ordinal shift of the modified Rankin Scale) in Asians (odds ratio, 1.05; 95% CI, 0.90-1.22) was consistent with non-Asians (odds ratio, 0.93; 95% CI, 0.76-1.14) (P = .32 for interaction).
    End point type
    Primary
    End point timeframe
    Randomisation to Day 90
    End point values
    		 Low Dose Alteplase Standard Dose Alteplase Intensive Blood Pressure Lowering Standard Blood Pressure Lowering
    Number of subjects analysed
    1607
    1599
    1072
    1108
    Units: Scale
        number (confidence interval 95%)
    1.05 (0.90 to 1.22)
    1.05 (0.90 to 1.22)
    1.01 (0.87 to 1.17)
    1.01 (0.87 to 1.17)
    Statistical analysis title
    		 Ordinal Shift Analysis
    Statistical analysis description
    Ordinal shift of the modified Rankin Scale.
    Comparison groups
    Low Dose Alteplase v Standard Dose Alteplase
    Number of subjects included in analysis
    3206
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 = 0.32 [3]
    Method
    		 Regression, Logistic
    Confidence interval
    Notes
    [2] - The ENCHANTED trial did show that low-dose alteplase was non-inferior for overall functional recovery through ordinal analysis of the mRS and resulted in significantly less severe sICH than did standard-dose alteplase.
    [3] - Insignificant p value. However, reductions in rates of ICH with low-dose alteplase, although not statistically significant by age, ethnicity or severity of stroke.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Consent to Day 90 follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Serious Adverse Events - Intensive BP Group
    Reporting group description
    		 A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose results in death, is life-threatening requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.

    Reporting group title
    Serious Adverse Event - Guideline BP Group
    Reporting group description
    		 -

    Reporting group title
    Serious Adverse Event - Low Dose Alteplase Group
    Reporting group description
    		 -

    Reporting group title
    Serious Adverse Event - Standard Dose Alteplase Group
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only Serious Adverse Events were collected for this study.
    Serious adverse events
    		 Serious Adverse Events - Intensive BP Group Serious Adverse Event - Guideline BP Group Serious Adverse Event - Low Dose Alteplase Group Serious Adverse Event - Standard Dose Alteplase Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    277 / 1081 (25.62%)
    245 / 1115 (21.97%)
    559 / 1654 (33.80%)
    627 / 1643 (38.16%)
         number of deaths (all causes)
    102
    88
    141
    172
         number of deaths resulting from adverse events
    Investigations
    Other - Non Vascular
         subjects affected / exposed
    18 / 1081 (1.67%)
    26 / 1115 (2.33%)
    39 / 1654 (2.36%)
    63 / 1643 (3.83%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 26
    0 / 39
    0 / 63
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 16
    0 / 14
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    2 / 1081 (0.19%)
    1 / 1115 (0.09%)
    2 / 1654 (0.12%)
    1 / 1643 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Subarachnoid haemorrhage
         subjects affected / exposed
    3 / 1081 (0.28%)
    3 / 1115 (0.27%)
    4 / 1654 (0.24%)
    3 / 1643 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    Intracerebral haemorrhage
         subjects affected / exposed
    59 / 1081 (5.46%)
    100 / 1115 (8.97%)
    135 / 1654 (8.16%)
    152 / 1643 (9.25%)
         occurrences causally related to treatment / all
    0 / 59
    0 / 100
    0 / 135
    0 / 152
         deaths causally related to treatment / all
    0 / 21
    0 / 22
    0 / 22
    0 / 41
    Intracranial haemorrhage
         subjects affected / exposed
    66 / 1081 (6.11%)
    105 / 1115 (9.42%)
    0 / 1654 (0.00%)
    0 / 1643 (0.00%)
         occurrences causally related to treatment / all
    0 / 66
    0 / 105
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 25
    0 / 24
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    64 / 1081 (5.92%)
    67 / 1115 (6.01%)
    118 / 1654 (7.13%)
    97 / 1643 (5.90%)
         occurrences causally related to treatment / all
    0 / 61
    0 / 45
    0 / 118
    0 / 97
         deaths causally related to treatment / all
    0 / 25
    0 / 33
    0 / 61
    0 / 45
    Undifferentiated Stroke
         subjects affected / exposed
    8 / 1081 (0.74%)
    11 / 1115 (0.99%)
    20 / 1654 (1.21%)
    28 / 1643 (1.70%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
    0 / 20
    0 / 28
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 5
    Other Vascular
         subjects affected / exposed
    27 / 1081 (2.50%)
    23 / 1115 (2.06%)
    55 / 1654 (3.33%)
    64 / 1643 (3.90%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 23
    0 / 55
    0 / 64
         deaths causally related to treatment / all
    0 / 9
    0 / 2
    0 / 16
    0 / 14
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    17 / 1081 (1.57%)
    10 / 1115 (0.90%)
    21 / 1654 (1.27%)
    19 / 1643 (1.16%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 10
    0 / 21
    0 / 19
         deaths causally related to treatment / all
    0 / 11
    0 / 7
    0 / 7
    0 / 13
    Blood and lymphatic system disorders
    Angioedema
         subjects affected / exposed
    0 / 1081 (0.00%)
    1 / 1115 (0.09%)
    4 / 1654 (0.24%)
    6 / 1643 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    40 / 1081 (3.70%)
    34 / 1115 (3.05%)
    63 / 1654 (3.81%)
    71 / 1643 (4.32%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 34
    0 / 63
    0 / 71
         deaths causally related to treatment / all
    0 / 21
    0 / 16
    0 / 28
    0 / 35
    Sepsis
         subjects affected / exposed
    8 / 1081 (0.74%)
    21 / 1115 (1.88%)
    27 / 1654 (1.63%)
    32 / 1643 (1.95%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 21
    0 / 27
    0 / 32
         deaths causally related to treatment / all
    0 / 4
    0 / 6
    0 / 4
    0 / 12
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Serious Adverse Events - Intensive BP Group Serious Adverse Event - Guideline BP Group Serious Adverse Event - Low Dose Alteplase Group Serious Adverse Event - Standard Dose Alteplase Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1081 (0.00%)
    0 / 1115 (0.00%)
    0 / 1654 (0.00%)
    0 / 1643 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Oct 2012
    Substantial Amendment 2 - Summary of Changes A4. Mrs Wendy Gamble added as Sponsor Representative (replaces Mr Graham Hewitt) A64-1. Mrs Wendy Gamble added as Sponsor Representative (replaces Mr Graham Hewitt) A65. Confirmation of award of Project Grant from The Stroke Association of value £210,055 (replaces Pending, £210,000) A71-2. Increase to 50 UK sites (replaces 25) A72. Increase to 47 England sites (replaces 22) Part B. Section 1. PR8. Details with respect to the addition of intravenous glyceryl trinitrate as a Test IMP Part C. Addition of Research Sites
    06 Feb 2013
    Substantial Amendment 3 - Summary of Changes 1. An alteration in the wording of the Participant and Legal Representative Information Sheets at the request of Sponsor Insurers to conform to their revised standard wording. 2. Revised Participant Consent and Legal Representative Assent Forms to refer to the correct versions of the Information Sheets. 3. Altered IMP labelling for Alteplase to enable the use of 10mg and 20mg strength vials, as well as 50mg vials (MHRA only). 4. Addition of new sites, including Principal Investigators. 5. Change in Principal Investigator as participating centres.
    07 Feb 2014
    Substantial Amendment 4 - Summary of Changes 1. Amendment to the protocol 2. Revised Participant and Legal Representative Information Sheets, and Participant Consent and Legal Representative Assent Forms, both Full and Short Versions. 3. Removal of existing sites. 4. Change in Principal Investigator details at participating sites
    10 Sep 2014
    Substantial Amendment 5 - Summary of Changes 1. Revised Participant and Legal Representative Information Sheets, and Participant Consent and Legal Representative Assent Forms, Full Versions only. 2. Removal of existing sites. 3. Change in Principal Investigator details at participating site. 4. Addition of new sites. 5. Request to increase UK total recruitment to 800.
    23 Mar 2015
    Substantial Amendment 6 - Summary of Changes 1. Addition of new site 2. Deletion of site 3. Change of PI at two sites
    02 Sep 2015
    Substantial Amendment 7 - Summary of Changes 1. Deletion of 3 sites 2. Change of PI at one site 3. Request to change UK total recruitment to 970
    05 Nov 2015
    Substantial Amendment 8 - Summary of Changes 1. Deletion of sites 2. Revised Participant and Legal Representative Information Sheets, and Participant Consent and Legal Representative Assent Forms, Full and Short versions.
    04 Jul 2016
    Substantial Amendment 9 - Summary of Changes 1. Change of Principal Investigator at sites 2. Addition of BP arm site 3. Deletion of 6 rtpa arm only sites 4. Submission of the published rtpa arm results paper

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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