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Stroke, AcutePhase 3INTERACT4NCT03790800

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

A Phase 3 study testing urapidil in people with Stroke, Acute and Cerebrovascular Disorders, run by The George Institute for Global Health, China at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute, Cerebrovascular Disorders
What is being tested?
urapidil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,425 participants
Where
4 sitesChina
Study dates
20 Mar 2020to 30 Nov 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • The George Institute for Global Health

    Beijing, Beijing Municipality, 100088

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China

    Chengdu, Sichuan, 610000

  • The First Affliated Hospital of Chengdu Medical College

    Chengdu, Sichuan, 610500

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

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).

Read the 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.

Being tested
urapidil
Keywords
stroke, blood pressure control, hypertension, clinical trial, ambulances
Medical subject headings
Stroke, Cerebrovascular Disorders, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • urapidilDrug

    Also called Intensive BP lowing

    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 groups in NCT03790800
Study groupRoleWhat they receive
Intervention groupExperimentalIf systolic blood pressure>180:IV Urapidil 25mg If systolic blood pressure>150 (or 5 mins after first bolus) : IV Urapidil 25mg and to maintain this level after admission to hospital in those with confirmed acute stroke for the next 7 days (or hospital discharge if earlier)
Receives: Drug: urapidil
control groupNo interventionTo receive blood pressure management according to standard local guidelines which recommend blood pressure lowering in hospital if systolic level is >220mmHg. This level will be considered by ambulance staff as a threshold for treatment if considered clinically important.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 90

Secondary outcomes (12)

  1. number of patients with serious adverse events

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

    Measured: Day 90

  2. number of patients with any intracranial hemorrhage

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

    Measured: Day 7

  3. size of cerebral infarction

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

    Measured: Day 2

  4. number of patients who receive reperfusion treatment

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

    Measured: Day 0

  5. time to use of reperfusion treatment

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

    Measured: Day 0

  6. size of hematoma volume

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

    Measured: Day 1

  7. size of hematoma volume

    volume of hematoma at baseline measured on brain imaging

    Measured: Day 0

  8. 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)

    Measured: Day 90

  9. Death

    Measured: Day 90

  10. 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.

    Measured: Day 90

  11. death or dependency measured by a shift in NIHSS

    Measured: day 1 and day 7

  12. Health related quality of life

    according to the EQ-5D

    Measured: day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2019
  2. Study start20 Mar 2020
  3. Primary completion23 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
central randomization with stratification
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,425 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03790800
Sponsor's protocol ID
INTERACT4
Acronym
INTERACT4
Status last verified
Mar 2025
First submitted
26 Dec 2018
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared with bona fide researchers after 1 year following conclusion of the study, based on a submitted protocol to the research office of The George Institute for Global Health, Sydney Australia

Publications

  • Ren X, Chen X, Hu X, Lin Y, Chen C, Wang J, Robinson TG, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Qureshi AI, Song L, Anderson C, Wang X; as the INTERACT and ATACH-II Investigators. Effects of Blood Pressure Lowering by Hematoma Location in Acute Intracerebral Hemorrhage. Neurology. 2026 Nov 10;107(9):e218514. doi: 10.1212/WNL.0000000000218514. Epub 2026 Oct 8.

    PubMed 42848972

  • 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. Systolic Blood Pressure Trajectory and Outcomes in Acute Intracerebral Hemorrhage: Pooled Analysis of the 4 INTERACT and ATACH-II Clinical Trials. Neurology. 2026 Apr 14;106(7):e214671. doi: 10.1212/WNL.0000000000214671. Epub 2026 Mar 19.

    PubMed 41855454

  • 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, Munoz-Venturelli P, Martins S, Pontes-Neto OM, Liu L, Chalmers J, Carcel C, Song L, Anderson CS; INTERACT Investigators. Effects of blood pressure lowering in relation to time in acute intracerebral haemorrhage: a pooled analysis of the four INTERACT trials. Lancet Neurol. 2025 Jul;24(7):571-579. doi: 10.1016/S1474-4422(25)00160-7.

    PubMed 40541207

  • Liu R, Chen C, Liu F, Lin Y, Chu H, Liu H, Anderson CS, Yang J, Li G, Song L, Ouyang M. Process Evaluation of an Ambulance-Delivered Early Intensive Blood Pressure-Lowering Stroke Trial: Design, Rationale, and Reflection. Cerebrovasc Dis. 2025;54(4):596-602. doi: 10.1159/000541322. Epub 2024 Sep 5.

    PubMed 39236681

  • Li G, Lin Y, Yang J, Anderson CS, Chen C, Liu F, Billot L, Li Q, Chen X, Liu X, Ren X, Zhang C, Xu P, Wu L, Wang F, Qiu D, Jiang M, Peng Y, Li C, Huang Y, Zhao X, Liang J, Wang Y, Wu X, Xu X, Chen G, Huang D, Zhang Y, Zuo L, Ma G, Yang Y, Hao J, Xu X, Xiong X, Tang Y, Guo Y, Yu J, Li S, He S, Mao F, Tan Q, Tan S, Yu N, Xu R, Sun M, Li B, Guo J, Liu L, Liu H, Ouyang M, Si L, Arima H, Bath PM, Ford GA, Robinson T, Sandset EC, Saver JL, Sprigg N, van der Worp HB, Song L; INTERACT4 investigators; INTERACT4 Investigators. Intensive Ambulance-Delivered Blood-Pressure Reduction in Hyperacute Stroke. N Engl J Med. 2024 May 30;390(20):1862-1872. doi: 10.1056/NEJMoa2314741. Epub 2024 May 16.

    PubMed 38752650

  • 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. Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants. Trials. 2023 Dec 20;24(1):817. doi: 10.1186/s13063-023-07861-5.

    PubMed 38124205

  • 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.

    PubMed 34872617

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing urapidil in people with Stroke, Acute and Cerebrovascular Disorders, run by The George Institute for Global Health, China at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

level of physical function (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03790800, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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