Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants

Chen Chen; Yapeng Lin; Feifeng Liu; Xiaoying Chen; Laurent Billot; Qiang Li; Yiija Guo; Hueiming Liu; Lei Si; Menglu Ouyang; Chunfang Zhang; Hisatomi Arima; Philip M. Bath; Gary A. Ford; Thompson Robinson; Else Charlotte Sandset; Jeffrey L. Saver; Nikola Sprigg; H. Bart van der Worp; Gang Liu; Lili Song; Jie Yang; Gang Li; Craig S. Anderson

doi:10.1186/s13063-023-07861-5

Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants

Chen Chen
, Yapeng Lin
, Feifeng Liu
, Xiaoying Chen
, Laurent Billot
, Qiang Li
, Yiija Guo
, Hueiming Liu
, Lei Si
, Menglu Ouyang
, Chunfang Zhang
, Hisatomi Arima
, Philip M. Bath
, Gary A. Ford
, Thompson Robinson
, Else Charlotte Sandset
, Jeffrey L. Saver
, Nikola Sprigg
, H. Bart van der Worp
, Gang Liu

Lili Song, Jie Yang, Gang Li, Craig S. Anderson

School of Health Sciences

The Department of Neurology
Tongji University
University of New South Wales
The George Institute for Global Health
Chengdu Medical College
Capital Medical University
Shanghai Pudong New District Medical Emergency Center
Fukuoka University
University of Nottingham
Oxford University Hospitals NHS Foundation Trust
University of Leicester
University of Oslo
Norwegian Air Ambulance Foundation
University of California at Los Angeles
Utrecht University
University of Electronic Science and Technology of China
Sichuan Provincial Key Laboratory for Human Disease Gene Study

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

Abstract

Background and aims: Uncertainty persists over the effects of blood pressure (BP) lowering in acute stroke. The INTEnsive ambulance-delivered blood pressure Reduction in hyper-Acute stroke Trial (INTERACT4) aims to determine efficacy and safety of hyperacute intensive BP lowering in patients with suspected acute stroke. Given concerns over the safety of this treatment in the pre-hospital setting, particularly in relation to patients with intracerebral hemorrhage, we provide an update on progress of the study and profile of participants to date. Methods: INTERACT4 is an ongoing multicentre, ambulance-delivered, randomized, open-label, blinded endpoint trial of pre-hospital BP lowering in patients with suspected acute stroke and elevated BP in China. Patients are randomized via a mobile phone digital system to intensive (target systolic BP [SBP] <140mmHg within 30 min) or guideline-recommended BP management. Primary outcome is an ordinal analysis of the full range of scores on the modified Rankin scale scores at 90 days. Results: Between March 2020 and April 2023, 2053 patients (mean age 70 years, female 39%) were recruited with a mean BP 178/98 mmHg in whom 45% have a diagnosis of primary intracerebral hemorrhage upon arrival at hospital. At the time of presentation to hospital, the mean SBP was 160 and 170mmHg in the intensive and control groups (Δ10 mmHg), respectively. The independent data and safety monitoring board has not identified any safety concerns and recommended continuation of the trial. The sample size was reduced from 3116 to 2320 after meetings in August 2022 as the stroke mimic rate was persistently lower than initially estimated (6% vs 30%). The study is expected to be completed in late 2023 and the results announced in May 2024. Conclusions: INTERACT4 is on track to provide reliable evidence of the effectiveness of ambulance-delivered intensive BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800 ; registered on 2 January 2019. Chinese Trial Registry ChCTR1900020534 , registered on 7 January 2019.

Original language	English
Article number	817
Number of pages	9
Journal	Trials
Volume	24
Issue number	1
DOIs	https://doi.org/10.1186/s13063-023-07861-5
Publication status	Published - Dec 2023

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Publisher Copyright:
© 2023, The Author(s).

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UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.1186/s13063-023-07861-5

Cite this

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, P. M., Ford, G. A., Robinson, T., Sandset, E. C., Saver, J. L., Sprigg, N., van der Worp, H. B., ... Anderson, C. S. (2023). Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants. Trials, 24(1), Article 817. https://doi.org/10.1186/s13063-023-07861-5

@article{169164f3484541419532de6196c8ddfb,

title = "Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants",

abstract = "Background and aims: Uncertainty persists over the effects of blood pressure (BP) lowering in acute stroke. The INTEnsive ambulance-delivered blood pressure Reduction in hyper-Acute stroke Trial (INTERACT4) aims to determine efficacy and safety of hyperacute intensive BP lowering in patients with suspected acute stroke. Given concerns over the safety of this treatment in the pre-hospital setting, particularly in relation to patients with intracerebral hemorrhage, we provide an update on progress of the study and profile of participants to date. Methods: INTERACT4 is an ongoing multicentre, ambulance-delivered, randomized, open-label, blinded endpoint trial of pre-hospital BP lowering in patients with suspected acute stroke and elevated BP in China. Patients are randomized via a mobile phone digital system to intensive (target systolic BP [SBP] <140mmHg within 30 min) or guideline-recommended BP management. Primary outcome is an ordinal analysis of the full range of scores on the modified Rankin scale scores at 90 days. Results: Between March 2020 and April 2023, 2053 patients (mean age 70 years, female 39\%) were recruited with a mean BP 178/98 mmHg in whom 45\% have a diagnosis of primary intracerebral hemorrhage upon arrival at hospital. At the time of presentation to hospital, the mean SBP was 160 and 170mmHg in the intensive and control groups (Δ10 mmHg), respectively. The independent data and safety monitoring board has not identified any safety concerns and recommended continuation of the trial. The sample size was reduced from 3116 to 2320 after meetings in August 2022 as the stroke mimic rate was persistently lower than initially estimated (6\% vs 30\%). The study is expected to be completed in late 2023 and the results announced in May 2024. Conclusions: INTERACT4 is on track to provide reliable evidence of the effectiveness of ambulance-delivered intensive BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800 ; registered on 2 January 2019. Chinese Trial Registry ChCTR1900020534 , registered on 7 January 2019.",

author = "Chen Chen and Yapeng Lin and Feifeng Liu and Xiaoying Chen and Laurent Billot and Qiang Li and Yiija Guo and Hueiming Liu and Lei Si and Menglu Ouyang and Chunfang Zhang and Hisatomi Arima and Bath, \{Philip M.\} and Ford, \{Gary A.\} and Thompson Robinson and Sandset, \{Else Charlotte\} and Saver, \{Jeffrey L.\} and Nikola Sprigg and \{van der Worp\}, \{H. Bart\} and Gang Liu and Lili Song and Jie Yang and Gang Li and Anderson, \{Craig S.\}",

note = "Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = dec,

doi = "10.1186/s13063-023-07861-5",

language = "English",

volume = "24",

journal = "Trials",

publisher = "BioMed Central Ltd.",

number = "1",

}

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 2023, 'Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants', Trials, vol. 24, no. 1, 817. https://doi.org/10.1186/s13063-023-07861-5

TY - JOUR

T1 - Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4)

T2 - progress and baseline features in 2053 participants

AU - Chen, Chen

AU - Lin, Yapeng

AU - Liu, Feifeng

AU - Chen, Xiaoying

AU - Billot, Laurent

AU - Li, Qiang

AU - Guo, Yiija

AU - Liu, Hueiming

AU - Si, Lei

AU - Ouyang, Menglu

AU - Zhang, Chunfang

AU - Arima, Hisatomi

AU - Bath, Philip M.

AU - Ford, Gary A.

AU - Robinson, Thompson

AU - Sandset, Else Charlotte

AU - Saver, Jeffrey L.

AU - Sprigg, Nikola

AU - van der Worp, H. Bart

AU - Liu, Gang

AU - Song, Lili

AU - Yang, Jie

AU - Li, Gang

AU - Anderson, Craig S.

PY - 2023/12

Y1 - 2023/12

N2 - Background and aims: Uncertainty persists over the effects of blood pressure (BP) lowering in acute stroke. The INTEnsive ambulance-delivered blood pressure Reduction in hyper-Acute stroke Trial (INTERACT4) aims to determine efficacy and safety of hyperacute intensive BP lowering in patients with suspected acute stroke. Given concerns over the safety of this treatment in the pre-hospital setting, particularly in relation to patients with intracerebral hemorrhage, we provide an update on progress of the study and profile of participants to date. Methods: INTERACT4 is an ongoing multicentre, ambulance-delivered, randomized, open-label, blinded endpoint trial of pre-hospital BP lowering in patients with suspected acute stroke and elevated BP in China. Patients are randomized via a mobile phone digital system to intensive (target systolic BP [SBP] <140mmHg within 30 min) or guideline-recommended BP management. Primary outcome is an ordinal analysis of the full range of scores on the modified Rankin scale scores at 90 days. Results: Between March 2020 and April 2023, 2053 patients (mean age 70 years, female 39%) were recruited with a mean BP 178/98 mmHg in whom 45% have a diagnosis of primary intracerebral hemorrhage upon arrival at hospital. At the time of presentation to hospital, the mean SBP was 160 and 170mmHg in the intensive and control groups (Δ10 mmHg), respectively. The independent data and safety monitoring board has not identified any safety concerns and recommended continuation of the trial. The sample size was reduced from 3116 to 2320 after meetings in August 2022 as the stroke mimic rate was persistently lower than initially estimated (6% vs 30%). The study is expected to be completed in late 2023 and the results announced in May 2024. Conclusions: INTERACT4 is on track to provide reliable evidence of the effectiveness of ambulance-delivered intensive BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800 ; registered on 2 January 2019. Chinese Trial Registry ChCTR1900020534 , registered on 7 January 2019.

AB - Background and aims: Uncertainty persists over the effects of blood pressure (BP) lowering in acute stroke. The INTEnsive ambulance-delivered blood pressure Reduction in hyper-Acute stroke Trial (INTERACT4) aims to determine efficacy and safety of hyperacute intensive BP lowering in patients with suspected acute stroke. Given concerns over the safety of this treatment in the pre-hospital setting, particularly in relation to patients with intracerebral hemorrhage, we provide an update on progress of the study and profile of participants to date. Methods: INTERACT4 is an ongoing multicentre, ambulance-delivered, randomized, open-label, blinded endpoint trial of pre-hospital BP lowering in patients with suspected acute stroke and elevated BP in China. Patients are randomized via a mobile phone digital system to intensive (target systolic BP [SBP] <140mmHg within 30 min) or guideline-recommended BP management. Primary outcome is an ordinal analysis of the full range of scores on the modified Rankin scale scores at 90 days. Results: Between March 2020 and April 2023, 2053 patients (mean age 70 years, female 39%) were recruited with a mean BP 178/98 mmHg in whom 45% have a diagnosis of primary intracerebral hemorrhage upon arrival at hospital. At the time of presentation to hospital, the mean SBP was 160 and 170mmHg in the intensive and control groups (Δ10 mmHg), respectively. The independent data and safety monitoring board has not identified any safety concerns and recommended continuation of the trial. The sample size was reduced from 3116 to 2320 after meetings in August 2022 as the stroke mimic rate was persistently lower than initially estimated (6% vs 30%). The study is expected to be completed in late 2023 and the results announced in May 2024. Conclusions: INTERACT4 is on track to provide reliable evidence of the effectiveness of ambulance-delivered intensive BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800 ; registered on 2 January 2019. Chinese Trial Registry ChCTR1900020534 , registered on 7 January 2019.

UR - https://hdl.handle.net/1959.7/uws:74359

U2 - 10.1186/s13063-023-07861-5

DO - 10.1186/s13063-023-07861-5

M3 - Article

C2 - 38124205

AN - SCOPUS:85180198665

VL - 24

JO - Trials

JF - Trials

IS - 1

M1 - 817

ER -

Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants

Abstract

Bibliographical note

Open Access - Access Right Statement

Notes

UN SDGs

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