Enhanced control of hypertension and thrombolysis stroke study

Phase 3

Completed

• Conditions: Hypertension; Ischaemic stroke; Stroke - Ischaemic; Cardiovascular - Hypertension

• Registration Number: ACTRN12611000236998
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-03
• Study Completion: 2018-08-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Patients with clinical diagnosis of acute ischaemic stroke confirmed by brain imaging within 4.5 hours of onset who fulfill local criteria for use of i.v. rtPA are potentially eligible if they have a sustained systolic BP level of 185 mmHg or below.
The attending clinician is required to sequentially consider their level of clinical uncertainty over the balance of potential benefits and risks pertaining to the appropriate dose of rtPA and the level of BP control in each particular patient, as outlined below.
Arm [A]: no definite indication/contraindication for either dose of rtPA; and able to pay for a 50mg vial of rtPA if in a fee-paying health system.
Arm [B]: 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RtPA dose arm: death and any disability (modified Rankin Scale [mRS] score 2-6) [90 days];Blood Pressure intensity arm: mRS ordinal shift[90 days]

Secondary Outcome Measures

Name	Time	Method
health-related quality of life by the EuroQoL[90 days];admission to residential care by in-person or telephone follow-up[90 days];health service including length of initial hospital stay, re-admission to hospital, visits to outpatient clinics, and visits to primary care physicians obtained by in-person or telephone follow-up[90 days];symptomatic intracerebral haemorrhage (confirmed by CT [or necropsy] with deterioration in NIH Stroke Scale [NIHSS] score)[36 hours];any intracerebral haemorrhage in CT scans[7 days];death or disability by shift analysis of scores on modified Rankin Scale (mRS)[90 days];death[90 days];disability (modified Rankin Scale [mRS] score 2-5)[90 days];neurological deterioration (deterioration in NIH Stroke Scale [NIHSS] score and/or Glasgow Coma Scale [GCS] score)[72 hours]