Diamanti Susanna, Beretta Simone, Tettamanti Mauro, Sacco Simona, Sette Giuliano, Ornello Raffaele, Tiseo Cindy, Caponnetto Valeria, Beccia Mario, Alivernini Diletta, Costanzo Rocco, Ferrarese Carlo
Stroke Unit and Neurology Unit, Azienda Socio Sanitaria Territoriale (ASST)-Monza San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.
Dipartimento di Ricerca Neuroscienze, Istituto di Ricerche Farmacologiche Mario Negri Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Milano, Italy.
Front Neurol. 2021 Nov 3;12:724050. doi: 10.3389/fneur.2021.724050. eCollection 2021.
To assess the efficacy of remote ischemic conditioning (RIC) in patients with ischemic stroke within 9 h of onset, that are not candidates for recanalization therapies. A sample size of 80 patients (40 in each arm) should yield 80% power to detect a 20% difference in early neurological improvement at 72 h at = 0.05, two sided. TRICS-9 is a phase II, multicenter, controlled, block randomized, open-label, interventional clinical trial. Patients recruited in Italian academic hospitals will be randomized 1:1 to either RIC plus standard medical therapy or standard medical therapy alone. After randomization, RIC will be applied manually by four alternating cycles of inflation/deflation 5 min each, using a blood pressure cuff around the non-paretic arm. The primary efficacy outcome is early neurological improvement, defined as the percent change in the National Institute of Health Stroke Scale (NIHSS) at 72 h in each arm. Secondary outcomes include early neurologic improvement at 24 and 48 h, disability at 3 months, rate of symptomatic intracerebral hemorrhage, feasibility (proportion of patients completing RIC), tolerability after RIC and at 72 h, blood levels of HIF-1α, and HSP27 at 24 h and 72 h. RIC in combination with recanalization therapies appears to add no clinical benefit to patients, but whether it is beneficial to those that are not candidates for recanalization therapies is still to be demonstrated. TRICS-9 has been developed to elucidate this issue. ClinicalTrials.gov, identifier: NCT04400981.
为评估远程缺血预处理（RIC）对发病9小时内不适合再通治疗的缺血性中风患者的疗效。样本量为80例患者（每组40例），在α = 0.05双侧检验时，应具有80%的检验效能以检测72小时时早期神经功能改善方面20%的差异。TRICS - 9是一项II期、多中心、对照、区组随机、开放标签的干预性临床试验。在意大利学术医院招募的患者将按1:1随机分为RIC联合标准药物治疗组或单纯标准药物治疗组。随机分组后，使用血压袖带在非患侧手臂上通过四个交替的充气/放气循环（每次5分钟）手动施加RIC。主要疗效指标是早期神经功能改善，定义为每组72小时时美国国立卫生研究院卒中量表（NIHSS）的变化百分比。次要指标包括24小时和48小时时的早期神经功能改善、3个月时的残疾情况、症状性脑出血发生率、可行性（完成RIC的患者比例）、RIC后及72小时时的耐受性、24小时和72小时时HIF - 1α和HSP27的血药浓度。RIC与再通治疗联合应用似乎对患者没有临床益处，但对于不适合再通治疗的患者是否有益仍有待证实。TRICS - 9旨在阐明这一问题。ClinicalTrials.gov标识符：NCT04400981。
