INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) : study protocol for a randomized controlled trial

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

doi:10.1186/s13063-021-05860-y

INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) : study protocol for a randomized controlled trial

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

Western Sydney University

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

19 Citations (Scopus)

Abstract

Background: Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). Methods: A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. Discussion: INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.

Original language	English
Article number	885
Number of pages	14
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05860-y
Publication status	Published - 2021

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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, P. M., Ford, G. A., Robinson, T., Sandset, E. C., Saver, J. L., Sprigg, N., van der Worp, H. B., ... Anderson, C. S. (2021). INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) : study protocol for a randomized controlled trial. Trials, 22(1), Article 885. https://doi.org/10.1186/s13063-021-05860-y

@article{3bc671b26a604dd0a40b679ec49dad03,

title = "INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) : study protocol for a randomized controlled trial",

abstract = "Background: Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). Methods: A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. Discussion: INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.",

author = "Lili Song and Chen Chen and Xiaoying Chen and Yijia Guo and Feifeng Liu and Yapeng Lin and Laurent Billot and Qiang Li and Hueiming Liu and Lei Si and Menglu Ouyang 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 Chunfang Zhang and Jie Yang and Gang Li and Anderson, {Craig S.}",

year = "2021",

doi = "10.1186/s13063-021-05860-y",

language = "English",

volume = "22",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

}

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 2021, 'INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) : study protocol for a randomized controlled trial', Trials, vol. 22, no. 1, 885. https://doi.org/10.1186/s13063-021-05860-y

TY - JOUR

T1 - INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) : study protocol for a randomized controlled trial

AU - Song, Lili

AU - Chen, Chen

AU - Chen, Xiaoying

AU - Guo, Yijia

AU - Liu, Feifeng

AU - Lin, Yapeng

AU - Billot, Laurent

AU - Li, Qiang

AU - Liu, Hueiming

AU - Si, Lei

AU - Ouyang, Menglu

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 - Zhang, Chunfang

AU - Yang, Jie

AU - Li, Gang

AU - Anderson, Craig S.

PY - 2021

Y1 - 2021

N2 - Background: Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). Methods: A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. Discussion: INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.

AB - Background: Early pre-hospital initiation of blood pressure (BP) lowering could improve outcomes for patients with acute stroke, by reducing hematoma expansion in intracerebral hemorrhage (ICH), and time to reperfusion treatment and risk of intracranial hemorrhage in ischemic stroke (IS). We present the design of the fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4). Methods: A multi-center, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) assessed trial of pre-hospital BP lowering in 3116 hypertensive patients with suspected acute stroke at 50+ sites in China. Patients are randomized through a mobile phone digital system to intensive BP lowering to a target systolic BP of < 140 mmHg within 30 min, or guideline-recommended BP management according to local protocols. After the collection of in-hospital clinical and management data and 7-day outcomes, trained blinded assessors conduct telephone or face-to-face assessments of physical function and health-related quality of life in participants at 90 days. The primary outcome is the physical function on the modified Rankin scale at 90 days, analyzed as an ordinal outcome with 7 categories. The sample size was estimated to provide 90% power (α = 0.05) to detect a 22% reduction in the odds of a worse functional outcome using ordinal logistic regression. Discussion: INTERACT4 is a pragmatic clinical trial to provide reliable evidence on the effectiveness and safety of ambulance-delivered hyperacute BP lowering in patients with suspected acute stroke. Trial registration: ClinicalTrials.gov NCT03790800. Registered on 2 January 2019; Chinese Trial Registry ChiCTR1900020534. Registered on 7 January 2019. All items can be found in this protocol paper.

UR - https://hdl.handle.net/1959.7/uws:67910

U2 - 10.1186/s13063-021-05860-y

DO - 10.1186/s13063-021-05860-y

M3 - Article

SN - 1745-6215

VL - 22

JO - Trials

JF - Trials

IS - 1

M1 - 885

ER -

INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) : study protocol for a randomized controlled trial

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