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

NCT ID: NCT03790800

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2023-11-30

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.

Conditions

Stroke, Acute; Cerebrovascular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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)

Group Type: EXPERIMENTAL

urapidil

Intervention Type: 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.

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

urapidil

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.

Intervention Type: DRUG

Other Intervention Names

Intensive BP lowing

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital, China

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Chengdu Medical College, China

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

The George Institute for Global Health, China

OTHER

Sponsor Role: lead

Responsible Party

Craig Anderson

Director, Global Brain Health program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Anderson

Role: PRINCIPAL_INVESTIGATOR

The George Institute for Global Health, China

Lili Song

Role: PRINCIPAL_INVESTIGATOR

The George Institute for Global Health, China

Gang Li

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital, China

Jie Yang

Role: PRINCIPAL_INVESTIGATOR

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

Yapeng Lin

Role: PRINCIPAL_INVESTIGATOR

The First Affliated Hospital of Chengdu Medical College, China

Locations

The George Institute for Global Health

Beijing, Beijing Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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

Chengdu, Sichuan, China

The First Affliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40541207 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38752650 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38124205 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34872617 (View on PubMed)

Other Identifiers

INTERACT4

Identifier Type: -

Identifier Source: org_study_id