ENhanced Control of Hypertension ANd Thrombolysis strokE stuDy

Not Applicable

Completed

• Conditions: Acute ischaemic stroke; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN82387104
• Lead Sponsor: The George Institute for Global Health (Australia)

Brief Summary

2015 rationale, design, and progress in: http://www.ncbi.nlm.nih.gov/pubmed/25832995 2018 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/30299230 2018 alteplase-dose arm results in: https://www.ncbi.nlm.nih.gov/pubmed/29571842 (added 29/05/2019) 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30739745 (added 29/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-04
• Study Completion: 2016-11-30
• Last Update Posted: 26 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4587

Inclusion Criteria

1. General criteria for use of thrombolytic treatment with rtPA:
1.1. Adult (age =18 years)
1.2. A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging
1.3. Able to receive treatment within 4.5 hours after the definite time of onset of symptoms
1.4. Have a systolic BP =185 mmHg (i.e. the guideline recommended level of eligibility for rtPA; patients with higher BP levels at presentation can still be included provided the BP is reduced to the entry level prior to commencement of the randomised treatment).
1.5. Provide informed consent (or via an appropriate proxy, according to local requirements)
2. Specific criteria for arm [A] of low-dose vs standard-dose rtPA.
2.1. No definite indication nor contraindication for either low-dose or standard-dose rtPA.
3. Specific criteria for arm [B] of intensive BP lowering vs guideline recommended BP control
3.1. Sustained elevated systolic BP level, defined as 2 readings =150 and =185 mmHg (i.e. the upper level for contraindication to use of thrombolysis)
3.2. No definite indication or contraindication to either immediate intensive? BP lowering (to a target of 140-150 mmHg systolic) versus guideline-based BP control (e.g. intensive BP lowering is feasible and does not appear to pose excessive hazard to the patient).

Exclusion Criteria

Patients will not be eligible if there is one or more of the following:
1. Unlikely to potentially benefit from the therapy (e.g. advanced dementia, known severe pre-stroke disability (mRS scores 3-5), or a very high likelihood of death within 24 hours of stroke onset
2. Other medical illness that interferes with outcome assessments and follow-uP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Compared with standard dose i.v. rtPA, low-dose rtPA is at least as effective (?not inferior?) on the major clinical outcome of death or any disability at 3 months (i.e. corresponding null hypothesis is that low-dose is inferior to standard dose rtPA);<br> 2. Compared with standard guideline-based BP management, early intensive BP lowering is superior in reducing the risk of the major clinical outcome of death or any disability at 3 months (i.e. corresponding null hypothesis is that there is no difference in treatments on this outcome)<br>