Acute ischaemic stroke
Conditions
Sponsors
The George Institute for Global Health Australia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - General criteria for use of thrombolytic treatment with rtPA. (a) Adult (age >18 years) (b) A clinical diagnosis of acute ischaemic stroke confirmed by brain imaging (c) Able to receive treatment within 4.5 hours after the definite time of onset of symptoms (d) 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) (e) Provide informed consent (or via an appropriate proxy, according to local requirements) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000
Exclusion criteria
Exclusion criteria: (a) Unlikely to potentially benefit from the therapy (e.g. advanced dementia), or a very high likelihood of death within 24 hours of stroke onset. (b) Other medical illness that interferes with outcome assessments and follow-up [known significant pre-stroke disability (mRS scores 2-5)]. (c) Specific contraindications to rtPA (Actilyse) or any of the blood pressure agents to be used. (d) Participation in another clinical trial involving evaluation of pharmacological agents (e) Need for following concomitant medication, including phosphodiesterase inhibitors and monoamine oxidase inhibitors.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes are: (a) symptomatic ICH based on NINDS criteria of brain imaging (or necropsy) confirmed ICH with 1 points deterioration in NIHSS score or death within 36 hours from baseline; (b) symptomatic ICH, defined by SITS-MOST criteria, as large (type II) parenchymal ICH with 4 points decline in NIHSS score or death within 36 hours from baseline; and (c) ICH of any type in brain imaging 7 days of treatment; (d) death or disability by the alternative, but less widely used, shift analysis of scores on the mRS, (e) death, (f) disability, (g) neurological deterioration 4 points decline in NIHSS score over 72 hours, (h) HRQoL by the EuroQoL, (i) admission to residential care, and (j) health service use for calculation of resources and costs.;Timepoint(s) of evaluation of this end point: Especified in each end point | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if: - 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 disability at 3 months (i.e. corresponding null hypothesis is that low-dose is inferior to standard dose rtPA); - 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 disability at 3 months (i.e. corresponding null hypothesis is that there is no difference in treatments on this outcome).;Secondary Objective: To investigate if: - Compared with standard dose i.v. rtPA, low-dose rtPA reduces the risk of sICH - Compared with standard guideline-based BP management, early intensive BP lowering after thrombolysis with rtPA reduces the risk of any ICH (i.e. corresponding null hypothesis is that there is no difference in the rate of any ICH between groups of differing intensities of BP lowering).;Primary end point(s): Primary outcome is the combined endpoint of death and disability as defined by the dichotomised 0-1 versus 2-6 cut-point on the modified Rankin Scale [mRS] at 3 months.;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Australia, Spain
Contacts
Public ContactEnrique Peña
Institut de Recerca HSCSP
Outcome results
None listed