drugset / Trial / NCT03790800
Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
Phase 3
Completed
2425 enrolled
The George Institute for Global Health, China
First Affiliated Hospital of Chengdu Medical College · collabShanghai East Hospital, China · collabSichuan Academy of Medical Sciences · collab
RandomizedParallel-groupSingle-blindTreatment
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).
Timeline
- Start
- 2020-03-20
- Primary completion
- 2023-11-23
- Completion
- 2023-11-30
Publications
- Wang X, Phan TG, Ren X, Ma HH, Li Q, Ouyang M, Delcourt C, Chen X, Wang J, Robinson TG, Arima H, Ma L, Hu X, You C, Liu L, Venturelli PM, Martins SC, Pontes-Neto OM, Chalmers JP, Song L, Qureshi AI, Anderson C. Systolic Blood Pressure Trajectory and Outcomes in Acute Intracerebral Hemorrhage: Pooled Analysis of the 4 INTERACT and ATACH-II Clinical Trials. Neurology. 2026 Apr 14;106(7):e214671. doi: 10.1212/WNL.0000000000214671. Epub 2026 Mar 19.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Urapidil | Small molecule | 25 mg | Intravenous |