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, for the INTERACT4 investigators, Craig S. Anderson, G. Li, J. Yang, Lili Song, Hisatomi Arima, Philip M. Bath, Thompson Robinson, Gary A. Ford, Nikola Sprigg, Else Charlotte Sandset, Jeffrey L. Saver, Bart H. van der Worp, Z. Liu, Jessica Dawson, Lily Y Wong, Bo Peng, Laurent Billot, Qing Li, Yanzhe Ning, Lili Song, Xiaoying Chen, Zexuan Yang, Wengui Yu, G. Li, C. Chen, Fang Liu, J. Yang, Yijia Guo, Yapeng Lin, R. HU, Hui Cheng, W. Ma, Kang-Lin Liao, C. Zhang, Hu Jin, G. Li, J. Yang, Ping Xu, Xintong Wu, F. Wang, Lingling Wu, Chun Wang, Yujing Peng, Xue Zhao, Xiaojun Xu, X. Liu, Xiaoming Song, Z. Li, Hao Zhang, Dehong Yu, Yi Wang, Xun Tang, H. Liu, Xiantong Cao, Y. Liu, Yifei Duan, H. Liu, Ching-Min Li, Jianxin Huang, Hezong Li, Chengcheng Fan, Yujie Tang, Yachen Ji, G. Li, Yining Huang, G. Chen, J. Wang
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.