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Finding appropriate drugs to improve cerebral autoregulation (CA) in patients with acute ischemic stroke (AIS) is necessary to improve prognosis. We aimed to investigate the effect of butylphthalide on CA in patients with AIS. In this randomized controlled trial, 99 patients were 2:1 randomized to butylphthalide or placebo group. The butylphthalide group received intravenous infusion with a preconfigured butylphthalide-sodium chloride solution for 14 days and an oral butylphthalide capsule for additional 76 days. The placebo group synchronously received an intravenous infusion of 100 mL 0.9% saline and an oral butylphthalide simulation capsule. The transfer function parameter, phase difference (PD), and gain were used to quantify CA. The primary outcomes were CA levels on the affected side on day 14 and day 90. Eighty patients completed the follow-up (52 in the butylphthalide group and 28 in the placebo group). The PD of the affected side on 14 days or discharge and on 90 days was higher in the butylphthalide group than in the placebo group. The differences in safety outcomes were not significant. Therefore, butylphthalide treatment for 90 days can significantly improve CA in patients with AIS. Trial registration: ClinicalTrial.gov: NCT03413202., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background Autonomic dysfunction has been revealed in patients with acute ischemic stroke and is associated with poor prognosis. However, autonomic nervous system function assessed by heart rate variability (HRV) and its relationship with clinical outcomes in patients undergoing intravenous thrombolysis (IVT) remain unknown. Methods and Results Patients who did and did not undergo IVT between September 2016 and August 2021 were prospectively and consecutively recruited. HRV values were measured at 1 to 3 and 7 to 10 days after stroke to assess autonomic nervous system function. A modified Rankin scale score ≥2 at 90 days was defined as an unfavorable outcome. Finally, the analysis included 466 patients; 224 underwent IVT (48.1%), and 242 did not (51.9%). Linear regression showed a positive correlation of IVT with parasympathetic activation-related HRV parameters at 1 to 3 days (high frequency: β =0.213, P =0.002) and with both sympathetic (low frequency: β =0.152, P =0.015) and parasympathetic activation-related HRV parameters (high frequency: β =0.153, P =0.036) at 7 to 10 days after stroke. Logistic regression showed HRV values and autonomic function within 1 to 3 and 7 to 10 days after stroke were independently associated with 3-month unfavorable outcomes after adjusting for confounders in patients who underwent IVT (all P <0.05). Furthermore, addition of HRV parameters to conventional risk factors significantly improved risk-predictive ability of 3-month outcome (the area under the receiver operating characteristic curve significantly improved from 0.784 [0.723-0.846] to 0.855 [0.805-0.906], P =0.002). Conclusions IVT positively affected HRV and autonomic nervous system activity, and autonomic function assessed by HRV in acute stroke phase was independently associated with unfavorable outcomes in patients undergoing IVT.

Rationale/aim: Many patients undergoing successful recanalization after endovascular thrombectomy (EVT) do not have a good outcome; additional neuroprotection might benefit this group. Remote ischemic conditioning (RIC) stimulates endogenous protective mechanisms and may have a neuroprotective in acute brain ischemia. The safety and efficacy of RIC combined with endovascular thrombectomy (SERIC-EVT) trial is investigating the safety and efficacy of RIC for patients with acute ischemic stroke (AIS) who underwent EVT due to large vessel occlusion of the anterior circulation., Methods: SERIC-EVT is a multicenter, randomized, parallel-controlled, and blinded endpoint clinical trial. Patients are recruited from 10 hospitals in Jilin Province, Northeast China. Patients with anterior circulation AIS undergoing EVT due to large vessel occlusion are randomized in a 1:1 ratio to RIC or sham-RIC. Participants will receive standard medical treatment and an inflation pressure of 200 mmHg (RIC group) or 60 mmHg (sham-RIC group) twice daily for seven consecutive days., Study Outcomes: The primary outcome is the proportion of patients with modified Rankin Scale (mRS) score of 0-2 on day 90. Secondary outcome measures include the National Institute of Health Stroke Scale, Barthel Index, and mRS scores obtained at 24 h, 7 days, 30 ± 3 days, and 90 ± 3 days post-EVT, recanalization rate, expanded Thrombolysis in Cerebral Infarction score, and symptomatic intracranial hemorrhage post-EVT. Mortality and all adverse events, including skin changes and pain scores, within the first 90 days will be used as safety outcome measures., Sample Size Estimates: Based on previous studies, we estimate a 14% difference in functional independence (the mRS ⩽2) between RIC and sham-RIC groups. Considering a significance level of 5% and power of 80%, and one-fifth of patients lost to follow up, the planned sample size is 498 patients (249 per group)., Discussion: RIC might be a strategy that improves 3-month clinical outcomes in AIS patients who have undergone EVT due to large vessel occlusion of anterior circulation. SERIC-EVT will determine whether this is the case.

Rationale: Remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) may improve functional outcomes in patients with acute ischemic stroke (AIS)., Aim: To assess the efficacy and safety of RIC combined with IVT for AIS., Methods and Design: SERIC-IVT is a multicenter, randomized, parallel-controlled, blinded endpoint clinical trial. A total of 558 patients with AIS who underwent IVT therapy will be randomly assigned 1:1 to receive RIC or sham-RIC plus standard medical therapy. The cuff pressures of the RIC group and the sham-RIC group will be 200 mm Hg and 60 mm Hg, respectively, performed twice a day for seven consecutive days., Study Outcomes: The primary efficacy outcome is the proportion of patients with a favorable functional outcome as defined as a modified Rankin Scale ⩽ 1 at 90 days. Safety outcomes include mortality and adverse events within 90 days., Sample Size Estimates: A sample size of 558 patients with AIS (279 in each group) will allow detection of a shift of 13.14% toward favorable functional outcome at 90 days (modified Rankin Scale ⩽ 1) with 5% significance and 80% power., Discussion: RIC is a promising adjuvant treatment for AIS. SERIC-IVT will inform on whether RIC treatment combined with IVT improves functional outcomes in AIS patients and identify any safety issues.