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NCT Number: NCT03790800

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

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).

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypertension Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The George Institute for Global Health, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥18 years;
  • 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;
  • Systolic BP ≥150
  • Able to provide brief informed consent (if a waver of consent is not approved by the ethics committee)

Exclusion criteria

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

Treatment and study plan

Urapidil

Drug

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.

Other names: Intensive BP lowing

Primary outcomes

  1. level of physical function

    Time frame: 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 outcomes

  1. number of patients with serious adverse events

    Time frame: Day 90

    total number of serious adverse events reported during follow-up, according to standard definitions

  2. number of patients with any intracranial hemorrhage

    Time frame: Day 7

    reperfusion treatment (thrombolysis/thrombectomy) related symptomatic intracerebral number of cases of intracranial hemorrhage, according to standard definitions

  3. size of cerebral infarction

    Time frame: Day 2

    overall size of cerebral infarction on MRI within 2 days in cases of ischaemic stroke

  4. number of patients who receive reperfusion treatment

    Time frame: Day 0

    total number of cases of reperfusion (thrombolysis and/or thrombectomy) in ischemic stroke

  5. time to use of reperfusion treatment

    Time frame: Day 0

    time from symptom onset to reperfusion treatment in patients with ischemic stroke

  6. size of hematoma volume

    Time frame: Day 1

    change in volume of hematoma from baseline to 24 hours, measured on brain imaging

  7. size of hematoma volume

    Time frame: Day 0

    volume of hematoma at baseline measured on brain imaging

  8. death or major disability

    Time frame: 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)

  9. Death

    Time frame: Day 90

  10. Disability

    Time frame: 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.

  11. death or dependency measured by a shift in NIHSS

    Time frame: day 1 and day 7

  12. Health related quality of life

    Time frame: day 90

    according to the EQ-5D

Sponsors and collaborators

Lead sponsor

The George Institute for Global Health, China

Other

Collaborators

  • First Affiliated Hospital of Chengdu Medical College
  • Shanghai East Hospital, China
  • Sichuan Academy of Medical Sciences

Registry information

Acronym: INTERACT4

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2019
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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