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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01422616




Registration number
NCT01422616
Ethics application status
Date submitted
23/08/2011
Date registered
24/08/2011
Date last updated
13/10/2021

Titles & IDs
Public title
Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED)
Scientific 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
Secondary ID [1] 0 0
X11-0123
Universal Trial Number (UTN)
Trial acronym
ENCHANTED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
High Blood Pressure 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Low-dose rtPA
Treatment: Drugs - Standard-dose rtPA
Other interventions - Intensive blood pressure (BP) lowering
Other interventions - BP management policies

Experimental: Low-dose rtPA (Recruitment completed in August 2015) - low-dose 0.6 mg/kg (maximum of 60 mg) i.v. rtPA

Active comparator: Standard-dose rtPA (Recruitment completed in August 2015) - standard-dose 0.9 mg/kg (maximum of 90 mg) i.v. rtPA

Experimental: Early intensive BP lowering - 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.

Active comparator: Control / guideline-based BP management - 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.


Treatment: Drugs: 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).

Treatment: Drugs: 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 interventions: 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 interventions: 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined death and disability
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
Symptomatic intracerebral hemorrhage
Timepoint [1] 0 0
36 hours
Secondary outcome [2] 0 0
Symptomatic intracerebral hemorrhage
Timepoint [2] 0 0
36 hours
Secondary outcome [3] 0 0
Death or disability by the alternative, ordinal shift analysis
Timepoint [3] 0 0
90 days
Secondary outcome [4] 0 0
Death
Timepoint [4] 0 0
at 7 and 90 days
Secondary outcome [5] 0 0
Disability
Timepoint [5] 0 0
90 days
Secondary outcome [6] 0 0
Neurological deterioration
Timepoint [6] 0 0
72 hours
Secondary outcome [7] 0 0
Health-related quality of life
Timepoint [7] 0 0
90 days
Secondary outcome [8] 0 0
Admission to residential care
Timepoint [8] 0 0
90 days
Secondary outcome [9] 0 0
Health service use
Timepoint [9] 0 0
90 days
Secondary outcome [10] 0 0
Symptomatic intracerebral hemorrhage (ICH)
Timepoint [10] 0 0
within 7 days
Secondary outcome [11] 0 0
Any intracerebral hemorrhage (ICH)
Timepoint [11] 0 0
any time during 90 days
Secondary outcome [12] 0 0
Death or disability in as treated per-protocol population
Timepoint [12] 0 0
90 days
Secondary outcome [13] 0 0
Death or disability in as treated per-protocol population
Timepoint [13] 0 0
90 days
Secondary outcome [14] 0 0
Death or neurological deterioration
Timepoint [14] 0 0
72 hours
Secondary outcome [15] 0 0
Length of initial acute hospital stay
Timepoint [15] 0 0
within 90 days
Secondary outcome [16] 0 0
Recurrent acute myocardial infarction and ischemic stroke
Timepoint [16] 0 0
within 90 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
Accrual to date
Final
4587
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Stroke Association, United Kingdom
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Takeda
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01422616
Trial related presentations / publications
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.
Huang Y, Sharma VK, Robinson T, Lindley RI, Chen X, Kim JS, Lavados P, Olavarria V, Arima H, Fuentes S, Nguyen HT, Lee TH, Parsons MW, Levi C, Demchuk AM, Bath PM, Broderick JP, Donnan GA, Martins S, Pontes-Neto OM, Silva F, Pandian J, Ricci S, Stapf C, Woodward M, Wang J, Chalmers J, Anderson CS; ENCHANTED investigators. Rationale, design, and progress of the ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy (ENCHANTED) trial: An international multicenter 2 x 2 quasi-factorial randomized controlled trial of low- vs. standard-dose rt-PA and early intensive vs. guideline-recommended blood pressure lowering in patients with acute ischaemic stroke eligible for thrombolysis treatment. Int J Stroke. 2015 Jul;10(5):778-88. doi: 10.1111/ijs.12486. Epub 2015 Apr 2.
Anderson CS, Woodward M, Arima H, Chen X, Lindley RI, Wang X, Chalmers J, Robinson TG. Statistical analysis plan for evaluating different intensities of blood pressure control in the ENhanced Control of Hypertension And Thrombolysis strokE stuDy. Int J Stroke. 2019 Jul;14(5):555-558. doi: 10.1177/1747493018806170. Epub 2018 Oct 9.
Anderson CS, Robinson T, Lindley RI, Arima H, Lavados PM, Lee TH, Broderick JP, Chen X, Chen G, Sharma VK, Kim JS, Thang NH, Cao Y, Parsons MW, Levi C, Huang Y, Olavarria VV, Demchuk AM, Bath PM, Donnan GA, Martins S, Pontes-Neto OM, Silva F, Ricci S, Roffe C, Pandian J, Billot L, Woodward M, Li Q, Wang X, Wang J, Chalmers J; ENCHANTED Investigators and Coordinators. Low-Dose versus Standard-Dose Intravenous Alteplase in Acute Ischemic Stroke. N Engl J Med. 2016 Jun 16;374(24):2313-23. doi: 10.1056/NEJMoa1515510. Epub 2016 May 10. Erratum In: N Engl J Med. 2018 Apr 12;378(15):1465-1466. doi: 10.1056/NEJMc1801548.
Anderson CS, Huang Y, Lindley RI, Chen X, Arima H, Chen G, Li Q, Billot L, Delcourt C, Bath PM, Broderick JP, Demchuk AM, Donnan GA, Durham AC, Lavados PM, Lee TH, Levi C, Martins SO, Olavarria VV, Pandian JD, Parsons MW, Pontes-Neto OM, Ricci S, Sato S, Sharma VK, Silva F, Song L, Thang NH, Wardlaw JM, Wang JG, Wang X, Woodward M, Chalmers J, Robinson TG; ENCHANTED Investigators and Coordinators. Intensive blood pressure reduction with intravenous thrombolysis therapy for acute ischaemic stroke (ENCHANTED): an international, randomised, open-label, blinded-endpoint, phase 3 trial. Lancet. 2019 Mar 2;393(10174):877-888. doi: 10.1016/S0140-6736(19)30038-8. Epub 2019 Feb 7.
Wang X, Minhas JS, Moullaali TJ, Di Tanna GL, Lindley RI, Chen X, Arima H, Chen G, Delcourt C, Bath PM, Broderick JP, Demchuk AM, Donnan GA, Durham AC, Lavados PM, Lee TH, Levi C, Martins SO, Olavarria VV, Pandian JD, Parsons MW, Pontes-Neto OM, Ricci S, Sato S, Sharma VK, Silva F, Thang NH, Wang JG, Woodward M, Chalmers J, Song L, Anderson CS, Robinson TG; ENCHANTED Investigators. Associations of Early Systolic Blood Pressure Control and Outcome After Thrombolysis-Eligible Acute Ischemic Stroke: Results From the ENCHANTED Study. Stroke. 2022 Mar;53(3):779-787. doi: 10.1161/STROKEAHA.121.034580. Epub 2021 Oct 27.
Zhou Z, Xia C, Mair G, Delcourt C, Yoshimura S, Liu X, Chen Z, Malavera A, Carcel C, Chen X, Wang X, Al-Shahi Salman R, Robinson TG, Lindley RI, Chalmers J, Wardlaw JM, Parsons MW, Demchuk AM, Anderson CS. Thrombolysis outcomes according to arterial characteristics of acute ischemic stroke by alteplase dose and blood pressure target. Int J Stroke. 2022 Jun;17(5):566-575. doi: 10.1177/17474930211025436. Epub 2021 Jun 24.
Zhou Z, Delcourt C, Xia C, Yoshimura S, Carcel C, Torii-Yoshimura T, You S, Malavera A, Chen X, Hackett ML, Woodward M, Chalmers J, Xu J, Robinson TG, Parsons MW, Demchuk AM, Lindley RI, Mair G, Wardlaw JM, Anderson CS. Low-Dose vs Standard-Dose Alteplase in Acute Lacunar Ischemic Stroke: The ENCHANTED Trial. Neurology. 2021 Mar 16;96(11):e1512-e1526. doi: 10.1212/WNL.0000000000011598. Epub 2021 Feb 3. Erratum In: Neurology. 2021 Sep 7;97(10):512. doi: 10.1212/WNL.0000000000012302.
Sun L, Song L, Yang J, Lindley RI, Robinson T, Lavados PM, Delcourt C, Arima H, Ovbiagele B, Chalmers J, Anderson CS, Wang X. Smoking influences outcome in patients who had thrombolysed ischaemic stroke: the ENCHANTED study. Stroke Vasc Neurol. 2021 Sep;6(3):395-401. doi: 10.1136/svn-2020-000493. Epub 2021 Feb 1.
Zhou Z, Xia C, Carcel C, Yoshimura S, Wang X, Delcourt C, Malavera A, Chen X, Mair G, Woodward M, Chalmers J, Demchuk AM, Lindley RI, Robinson TG, Parsons MW, Wardlaw JM, Anderson CS. Intensive versus guideline-recommended blood pressure reduction in acute lacunar stroke with intravenous thrombolysis therapy: The ENCHANTED trial. Eur J Neurol. 2021 Mar;28(3):783-793. doi: 10.1111/ene.14598. Epub 2020 Dec 1.
Minhas JS, Wang X, Lindley RI, Delcourt C, Song L, Woodward M, Lee TH, Broderick JP, Pontes-Neto OM, Kim JS, Ricci S, Lavados PM, Bath PM, Durham AC, Wang JG, Sharma VK, Demchuk AM, Martins SO, Chalmers J, Anderson CS, Robinson TG; ENCHANTED Investigators. Comparative effects of intensive-blood pressure versus standard-blood pressure-lowering treatment in patients with severe ischemic stroke in the ENCHANTED trial. J Hypertens. 2021 Feb 1;39(2):280-285. doi: 10.1097/HJH.0000000000002640.
Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.
Zhou Z, Yoshimura S, Delcourt C, Lindley RI, You S, Malavera A, Torii-Yoshimura T, Carcel C, Wang X, Chen X, Parsons MW, Demchuk AM, Wardlaw JM, Mair G, Robinson TG, Chalmers J, Xu J, Anderson CS. Thrombolysis Outcomes in Acute Ischemic Stroke by Fluid-Attenuated Inversion Recovery Hyperintense Arteries. Stroke. 2020 Jul;51(7):2240-2243. doi: 10.1161/STROKEAHA.119.028550. Epub 2020 Jun 17.
Chen X, Li J, Anderson CS, Lindley RI, Hackett ML, Robinson T, Lavados PM, Wang X, Arima H, Chalmers J, Delcourt C; ENCHANTED Investigators. Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm. Int J Stroke. 2021 Feb;16(2):222-228. doi: 10.1177/1747493019897858. Epub 2020 Jan 22.
Chen X, Wang X, Delcourt C, Li J, Arima H, Hackett ML, Robinson T, Lavados PM, Lindley RI, Chalmers J, Anderson CS; ENCHANTED Investigators. Ethnicity and Other Determinants of Quality of Functional Outcome in Acute Ischemic Stroke: The ENCHANTED Trial. Stroke. 2020 Feb;51(2):588-593. doi: 10.1161/STROKEAHA.119.027639. Epub 2019 Dec 11.
Wang X, Song L, Yang J, Sun L, Moullaali TJ, Sandset EC, Delcourt C, Lindley RI, Robinson TG, Minhas JS, Arima H, Chalmers J, Kim JS, Sharma V, Wang JG, Pontes-Neto O, Lavados PM, Olavarria VV, Lee TH, Levi C, Martins SO, Thang NH, Anderson CS; on behalf of the ENCHANTED Investigators. Interaction of Blood Pressure Lowering and Alteplase Dose in Acute Ischemic Stroke: Results of the Enhanced Control of Hypertension and Thrombolysis Stroke Study. Cerebrovasc Dis. 2019;48(3-6):207-216. doi: 10.1159/000504745. Epub 2019 Dec 6.
Robinson TG, Bray BD, Paley L, Sprigg N, Wang X, Arima H, Bath PM, Broderick JP, Durham AC, Kim JS, Lavados PM, Lee TH, Martins S, Nguyen TH, Pandian JD, Parsons MW, Pontes-Neto OM, Ricci S, Sharma VK, Wang J, Woodward M, Rudd AG, Chalmers J, S Anderson C; ENCHANTED Investigators and the SSNAP Collaboration. Applicability of ENCHANTED trial results to current acute ischemic stroke patients eligible for intravenous thrombolysis in England and Wales: Comparison with the Sentinel Stroke National Audit Programme registry. Int J Stroke. 2019 Oct;14(7):678-685. doi: 10.1177/1747493019841246. Epub 2019 Apr 8.
Robinson TG, Wang X, Durham AC, Ford GA, Liao J, Littlewood S, Roffe C, White P, Chalmers J, Anderson CS; ENCHANTED Investigators. The National Institute for Health Research Hyperacute Stroke Research Centres and the ENCHANTED trial: the impact of enhanced research infrastructure on trial metrics and patient outcomes. Health Res Policy Syst. 2019 Feb 13;17(1):19. doi: 10.1186/s12961-019-0417-2.
Yoshimura S, Lindley RI, Carcel C, Sato S, Delcourt C, Wang X, Chalmers J, Anderson CS; ENCHANTED Investigators. NIHSS cut point for predicting outcome in supra- vs infratentorial acute ischemic stroke. Neurology. 2018 Oct 30;91(18):e1695-e1701. doi: 10.1212/WNL.0000000000006437. Epub 2018 Sep 28.
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.
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.
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.
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.
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. doi: 10.1001/jamaneurol.2017.4512.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Craig S Anderson, MD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01422616