Blood pressure management strategy in patients with acute ischemic stroke after mechanical thrombectomy (CHASE-MT): A prospective, multicenter, randomized controlled, open-label clinical trial protocol

Abstract

AbstractBackground The efficient control of blood pressure (BP) after mechanical thrombectomy (MT) has not been determined, and there is a lack of multicenter, prospective, randomized controlled, open-label clinical studies on the precise management of BP in patients with acute ischemic stroke (AIS) after undergoing MT. This trial aims to determine whether potent antihypertensive therapy (90–110 mmHg) effectively reduces the incidence of symptomatic hemorrhagic transformation at 48 h after MT and the incidence of poor prognosis at 90 days after therapy in patients with AIS. Methodology/Design: This is a randomized, controlled, open-label, prospective, multicenter clinical trial. Patients with AIS treated with MT will be screened. A total of 324 adult patients with AIS (National Institutes of Health Stroke Scale (NIHSS) score, 6–19 points) will be recruited from 11 sites located in Shaanxi and Gansu pration system. The primary outcome measure is the proportion of patients in the trial group with a good prognosis (modified Rankin scale (mRS) score ≤ 2 points) at 90 days after treatment compared with the control group. The secondary outcome measures are the incidence of sICH due to reperfusion injury within 48 h after therapy, NIHSS score at 48 h after therapy, and mRS score at 14 days after therapy in both groups. Demographic characteristics, relevant medical history, characteristics of the occluded vessels, perioperative treatment, and monitoring results will be collected from all study subjects. The relationship between BP levels in AIS patients at 48 after successful recanalization and symptomatic hemorrhagic transformation and clinical prognosis will be explored. Discussion The CHASE-MT trial will be a large multicenter study that actively explores BP management strategies in patients with AIS undergoing MT. This trial has the potential to address the persistent BP elevation or high postoperative BP variability after successful recanalization in patients with AIS and to provide optimal BP levels. Trial registration: This trial was registered at ClinicalTrials.gov (Identifier: NCT05282290, Date of registration: June 13, 2022).