A multicentre, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) study to assess the effects of hyperacute intensive blood pressure (BP) lowering initiated in ambulance setting on (i) functional outcome in patients with acute stroke (ii) safety in patients with confirmed acute stroke and other conditions that were initially suspected as acute stroke (i.e. stroke mimic).
As an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. INTERACT4 aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mRS, the safety in all randomised patients; reperfusion treatment (thrombolysis and/or thrombectomy) related symptomatic ICH (sICH, according to standard definitions), infarct size, the time to and overall rate of reperfusion treatment in AIS patients; hematoma volume and early expansion in ICH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,425
A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25mg urapidil bolus will be given if the systolic blood pressure level persists \>150 after 5 minutes.
The George Institute for Global Health
Beijing, Beijing Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
Chengdu, Sichuan, China
The First Affliated Hospital of Chengdu Medical College
Chengdu, Sichuan, China
level of physical function
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Time frame: Day 90
number of patients with serious adverse events
total number of serious adverse events reported during follow-up, according to standard definitions
Time frame: Day 90
number of patients with any intracranial hemorrhage
reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions
Time frame: Day 7
size of cerebral infarction
overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke
Time frame: Day 2
number of patients who receive reperfusion treatment
total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke
Time frame: Day 0
time to use of reperfusion treatment
time from symptom onset to reperfusion treatment in patients with ischemic stroke
Time frame: Day 0
size of hematoma volume
change in volume of hematoma from baseline to 24 hours, measured on brain imaging
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Time frame: Day 1
size of hematoma volume
volume of hematoma at baseline measured on brain imaging
Time frame: Day 0
death or major disability
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. mRS(3-6)
Time frame: Day 90
Death
Time frame: Day 90
Disability
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Time frame: Day 90
death or dependency measured by a shift in NIHSS
Time frame: day 1 and day 7
Health related quality of life
according to the EQ-5D
Time frame: day 90