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Update on the INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4): progress and baseline features in 2053 participants.
Chen, Chen; Lin, Yapeng; Liu, Feifeng; Chen, Xiaoying; Billot, Laurent; Li, Qiang; Guo, Yiija; Liu, Hueiming; Si, Lei; Ouyang, Menglu; Zhang, Chunfang; Arima, Hisatomi; Bath, Philip M; Ford, Gary A; Robinson, Thompson; Sandset, Else Charlotte; Saver, Jeffrey L; Sprigg, Nikola; van der Worp, H Bart; Liu, Gang; Song, Lili; Yang, Jie; Li, Gang; Anderson, Craig S.
Afiliación
  • Chen C; Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, 1800, Yuntai Road, Shanghai, 200120, China.
  • Lin Y; The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, Missenden Rd., Sydney, NSW, 2050, Australia.
  • Liu F; The George Institute for Global Health, Room 011, Unit 2, Tayuan Diplomatic Office Building, No. 14 Liangmahe Nan Lu, Chaoyang District, Beijing, 100600, China.
  • Chen X; Department of Neurology, Clinical Medical College and The First Affiliated Hospital of Chengdu Medical College, Chengdu, China.
  • Billot L; International Clinical Research Centre, Chengdu Medical College, Chengdu, China.
  • Li Q; Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, 1800, Yuntai Road, Shanghai, 200120, China.
  • Guo Y; The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, Missenden Rd., Sydney, NSW, 2050, Australia.
  • Liu H; The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, Missenden Rd., Sydney, NSW, 2050, Australia.
  • Si L; The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, Missenden Rd., Sydney, NSW, 2050, Australia.
  • Ouyang M; Beijing Municipal Key Laboratory of Clinical Epidemiology, School of Public Health, Capital Medical University, Beijing, China.
  • Zhang C; Beijing Chest Hospital, Capital Medical University, Beijing, China.
  • Arima H; The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, Missenden Rd., Sydney, NSW, 2050, Australia.
  • Bath PM; School of Health Sciences, Western Sydney University, Campbelltown, Australia.
  • Ford GA; Translational Health Research Institute, Western Sydney University, Penrith, Australia.
  • Robinson T; The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, Missenden Rd., Sydney, NSW, 2050, Australia.
  • Sandset EC; Shanghai Pudong New Area Medical Emergency Centre, Shanghai, China.
  • Saver JL; The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, Missenden Rd., Sydney, NSW, 2050, Australia.
  • Sprigg N; Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
  • van der Worp HB; Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
  • Liu G; Oxford University Hospitals NHS Foundation Trust and University of Oxford, Oxford, UK.
  • Song L; College of Life Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.
  • Yang J; Department of Neurology, Oslo University Hospital, Oslo, Norway.
  • Li G; Norwegian Air Ambulance Foundation, Oslo, Norway.
  • Anderson CS; University of California, Los Angeles, USA.
Trials ; 24(1): 817, 2023 Dec 20.
Article en En | MEDLINE | ID: mdl-38124205
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Accidente Cerebrovascular / Hipertensión / Hipotensión Límite: Aged / Female / Humans / Male Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
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Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Accidente Cerebrovascular / Hipertensión / Hipotensión Límite: Aged / Female / Humans / Male Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido