Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University, 1800, Yuntai Road, Shanghai, 200120, China.
The George Institute for Global Health, Faculty of Medicine, UNSW, PO Box M201, Missenden Rd., Sydney, NSW, 2050, Australia.
Trials. 2023 Dec 20;24(1):817. doi: 10.1186/s13063-023-07861-5.
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.
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.
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.
INTERACT4 is on track to provide reliable evidence of the effectiveness of ambulance-delivered intensive BP lowering in patients with suspected acute stroke.
ClinicalTrials.gov NCT03790800 ; registered on 2 January 2019. Chinese Trial Registry ChCTR1900020534 , registered on 7 January 2019.
血压（BP）降低在急性脑卒中中的作用仍存在不确定性。INTEnsive 救护车送达的血压在超急性脑卒中试验（INTERACT4）旨在确定疑似急性脑卒中患者超急性强化降压的疗效和安全性。鉴于该治疗在院前环境中的安全性存在担忧，特别是与颅内出血患者相关，我们提供了研究进展和迄今为止参与者特征的最新情况。
INTERACT4 是一项正在进行的多中心、救护车送达、随机、开放标签、盲终点试验，在中国对疑似急性脑卒中且血压升高的患者进行院前降压。患者通过移动电话数字系统随机分为强化组（目标收缩压 [SBP] 在 30 分钟内<140mmHg）或指南推荐的降压管理组。主要结局是 90 天时改良 Rankin 量表评分的全范围的有序分析。
2020 年 3 月至 2023 年 4 月期间，共招募了 2053 例患者（平均年龄 70 岁，女性 39%），入院时平均血压为 178/98mmHg，其中 45%在到达医院时被诊断为原发性颅内出血。在入院时，强化组和对照组的平均 SBP 分别为 160mmHg 和 170mmHg（差值为 10mmHg）。独立的数据和安全监测委员会未发现任何安全问题，并建议继续进行试验。2022 年 8 月会议后，该研究的样本量从 3116 例减少至 2320 例，因为脑卒中模拟率持续低于最初估计值（6%比 30%）。该研究预计将于 2023 年底完成，并于 2024 年 5 月公布结果。
INTERACT4 有望为疑似急性脑卒中患者的救护车送达强化降压提供可靠的疗效证据。
ClinicalTrials.gov NCT03790800；注册于 2019 年 1 月 2 日。Chinese Trial Registry ChCTR1900020534，注册于 2019 年 1 月 7 日。
