Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial

Conditions

Stroke, Acute, Cerebrovascular Disorders

Keywords

stroke, blood pressure control, hypertension, clinical trial, ambulances

Brief summary

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).

Detailed description

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.

Wang X, Phan TG, Ren X, Ma HH, Li Q, Ouyang M, Delcourt C, Chen X, Wang J, Robinson TG, Arima H, Ma L, Hu X, You C, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Chalmers JP, Song L, Qureshi AI, Anderson C.

2026-03-19

10.1212/wnl.0000000000214671

Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials.

Wang X, Ren X, Li Q, Ouyang M, Chen C, Delcourt C, Chen X, Wang J, Robinson T, Arima H, Ma L, Hu X, You C, Li G, Jie Y, Lin Y, Billot L, Muñoz-Venturelli P, Martins S, Pontes-Neto OM, Liu L, Chalmers J, Carcel C, Song L, Anderson CS, INTERACT Investigators.

2025-07-019 citations

10.1016/s1474-4422(25)00160-7

Intensive Ambulance-Delivered Blood-Pressure Reduction in Hyperacute Stroke

Gang Li, Yapeng Lin, Jie Yang, Craig S. Anderson, Chen Chen et al. (60 authors)

New England Journal of Medicine2024-05-16133 citations

10.1056/nejmoa2314741

Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants.

Chen C, Lin Y, Liu F, Chen X, Billot L, Li Q, Guo Y, Liu H, Si L, Ouyang M, Zhang C, Arima H, Bath PM, Ford GA, Robinson T, Sandset EC, Saver JL, Sprigg N, van der Worp HB, Liu G, Song L, Yang J, Li G, Anderson CS, INTERACT4 Investigators.

2023-12-204 citations

10.1186/s13063-023-07861-5

Prehospital transdermal glyceryl trinitrate in patients with ultra-acute presumed stroke (RIGHT-2): effects on outcomes at day 365 in a randomised, sham-controlled, blinded, phase III, superiority ambulance-based trial

Lisa J Woodhouse, Jason P. Appleton, Sandeep Ankolekar, Timothy J. England, Grant Mair et al. (17 authors)

BMJ Neurology Open2023-06-011 citations

10.1136/bmjno-2023-000424

INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial.

Song L, Chen C, Chen X, Guo Y, Liu F, Lin Y, Billot L, Li Q, Liu H, Si L, Ouyang M, Arima H, Bath PM, Ford GA, Robinson T, Sandset EC, Saver JL, Sprigg N, van der Worp HB, Zhang C, Yang J, Li G, Anderson CS, INTERACT4 investigators.

2021-12-0623 citations

10.1186/s13063-021-05860-y

Impact of COVID-19 on Patient Behavior to Stroke Symptoms in China

Lili Song, Menglu Ouyang, Lingli Sun, Chen Chen, Craig S. Anderson

Cerebrovascular Diseases2020-01-0114 citations

10.1159/000511394

Interventions

DRUGurapidil

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Outcome assessor is independent of the treatment team

Intervention model description

central randomization with stratification

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1. age ≥18 years; 2. Acute syndrome that is due to presumed acute stroke, defined as FAST（Face, Arm, Speech, Time） scores of ≥2 with an arm motor deficit and time ≤2 hours from last seen well; 3. Systolic BP ≥150 4. Able to provide brief informed consent (if a waver of consent is not approved by the ethics committee)

Exclusion criteria

1. Coma - no response to tactile stimuli or verbal stimuli; 2. Severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia,severe heart failure,pre-stroke disability\[needed help\]); 3. History of epilepsy or seizure at onset; 4. History of recent head injury (\<7 days); 5. Hypoglycemia(glucose\<2.8mmol/L)

Design outcomes

Primary

Measure	Time frame	Description
level of physical function	Day 90	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.

Secondary

Measure	Time frame	Description
number of patients with any intracranial hemorrhage	Day 7	reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions
size of cerebral infarction	Day 2	overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke
number of patients who receive reperfusion treatment	Day 0	total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke
time to use of reperfusion treatment	Day 0	time from symptom onset to reperfusion treatment in patients with ischemic stroke
size of hematoma volume	Day 1	change in volume of hematoma from baseline to 24 hours, measured on brain imaging
number of patients with serious adverse events	Day 90	total number of serious adverse events reported during follow-up, according to standard definitions
Death	Day 90	—
Disability	Day 90	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.
death or dependency measured by a shift in NIHSS	day 1 and day 7	—
Health related quality of life	day 90	according to the EQ-5D
death or major disability	Day 90	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)

Countries

China

Outcome results

None listed