Clinical trial NCT03790800: Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Official title: Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke, Acute
Cerebrovascular Disorders
Keywords: stroke
blood pressure control
hypertension
clinical trial
ambulances
Lead sponsor: The George Institute for Global Health, China
Sponsor class: OTHER
Collaborators: name: Shanghai East Hospital, China
name: First Affiliated Hospital of Chengdu Medical College, China
name: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
First posted: 2019-01-02
Enrollment: 2425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: central randomization with stratification
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: level of physical function
timeFrame: Day 90
Secondary outcomes:
measure: number of patients with serious adverse events
timeFrame: Day 90
measure: number of patients with any intracranial hemorrhage
timeFrame: Day 7
measure: size of cerebral infarction
timeFrame: Day 2
measure: number of patients who receive reperfusion treatment
timeFrame: Day 0
measure: time to use of reperfusion treatment
timeFrame: Day 0
measure: size of hematoma volume
timeFrame: Day 1
measure: size of hematoma volume
timeFrame: Day 0
measure: death or major disability
timeFrame: Day 90
measure: Death
timeFrame: Day 90
measure: Disability
timeFrame: Day 90
measure: death or dependency measured by a shift in NIHSS
timeFrame: day 1 and day 7
measure: Health related quality of life
timeFrame: day 90
Other outcomes:
Locations:
city: Beijing
country: China
facility: The George Institute for Global Health
state: Beijing
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
state: Sichuan
city: Chengdu
country: China
facility: The First Affliated Hospital of Chengdu Medical College
state: Sichuan
Study officials:
affiliation: The George Institute for Global Health, China
name: Craig Anderson
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Institute for Global Health, China
name: Lili Song
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai East Hospital, China
name: Gang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China
name: Jie Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affliated Hospital of Chengdu Medical College, China
name: Yapeng Lin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): study protocol for a randomized controlled trial. Trials. 2021 Dec 6;22(1):885. doi: 10.1186/s13063-021-05860-y.