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

NCT03790800 | Completed Phase 3 DMC

• 1 other identifier: INTERACT4
• Study Type: interventional
• Target: 2,425
• Locations: 1 country
• Sites: 4

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).

Conditions

Stroke, Acute; Cerebrovascular Disorders

Keywords

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

Outcome Measures

Primary Outcomes (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.

  Day 90

Secondary Outcomes (12)

• number of patients with serious adverse events

  Day 90

• number of patients with any intracranial hemorrhage

  Day 7

• size of cerebral infarction

  Day 2

• number of patients who receive reperfusion treatment

  Day 0

• time to use of reperfusion treatment

  Day 0

Study Arms (2)

Intervention group

EXPERIMENTAL

If 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)

Drug: urapidil

control group

NO INTERVENTION

To 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.

Interventions

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.

Also known as: Intensive BP lowing

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• The George Institute for Global Health, China: lead
• Shanghai East Hospital, China: collaborator
• First Affiliated Hospital of Chengdu Medical College, China: collaborator
• Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, China: collaborator

Study Sites (4)

The George Institute for Global Health

Beijing, Beijing Municipality, 100088, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

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

Chengdu, Sichuan, 610000, China

Location

The First Affliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610500, China

Location

Related Publications (4)

• 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.

  PMID: 40541207 DERIVED

• 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.

  PMID: 38752650 DERIVED

• 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.

  PMID: 38124205 DERIVED

• 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.

  PMID: 34872617 DERIVED

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Hypertension

Interventions

urapidil

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Craig Anderson

  The George Institute for Global Health, China

  PRINCIPAL INVESTIGATOR

• Lili Song

  The George Institute for Global Health, China

  PRINCIPAL INVESTIGATOR

• Gang Li

  Shanghai East Hospital, China

  PRINCIPAL INVESTIGATOR

• Jie Yang

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

  PRINCIPAL INVESTIGATOR

• Yapeng Lin

  The First Affliated Hospital of Chengdu Medical College, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor is independent of the treatment team
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Global Brain Health program

Model Details: central randomization with stratification

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: January 2, 2019
• Study Start: March 20, 2020
• Primary Completion: November 23, 2023
• Study Completion: November 30, 2023
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year after conclusion of the study
• Access Criteria: genuine researcher with supporting institution protocol review and approval by the research office of The George Institute

Locations

CN (4)