NeuroThera® Efficacy and Safety Trial – 3 (NEST-3): A Double-Blind, Randomized, Sham-Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy with the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke within 24 h of Stroke Onset

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

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Efficacy and Safety of Panax Notoginseng Saponins (Xueshuantong) in Patients With Acute Ischemic Stroke (EXPECT) Trial: Rationale and Design

Frontiers in Pharmacology ◽

10.3389/fphar.2021.648921 ◽

2021 ◽

Vol 12 ◽

Author(s):

Luda Feng ◽

Fang Han ◽

Li Zhou ◽

Shengxian Wu ◽

Yawei Du ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Panax Notoginseng ◽

Double Blind Study ◽

Efficacy And Safety ◽

Panax Notoginseng Saponins ◽

Double Blind ◽

Nihss Score ◽

Positive Effects ◽

Patient Reported

Background: Although revascularization treatment is recommended as the first-line therapy for patients with non-minor acute ischemic stroke (AIS), it only benefits a minority of patients. Previous studies have reported the positive effects of Panax notoginseng saponins (PNS) (Xueshuantong lyophilized powder) on AIS, however, there have been no rigorous trials. This study aims to assess the efficacy and safety of PNS therapy for patients with AIS.Methods: The Evaluation of Xueshuantong in Patients with acutE ischemiC sTroke (EXPECT) trial is a multicenter, randomized, placebo-controlled, double-blind study aiming to enroll 480 patients in China. Eligible patients with AIS within 72 h of symptom onset will randomly receive either PNS or PNS placebo for 10 days and subsequently be followed up to 90 days. The primary outcome will be a change in the National Institute of Health Stroke Scale (NIHSS) score from baseline to 10 post-randomization days. The secondary outcomes include early neurological improvement (proportion of patients with NIHSS score 0–1), and Patient-Reported Outcomes Scale for Stroke score at 10 post-randomization days, the proportion of patients with life independence (modified Rankin Scale score of 0–1), the proportion of patients with a favorable outcome (Barthel Index ≥90), and Stroke-Specific Quality of Life score at 90 days. Adverse events or clinically significant changes in vital signs and laboratory parameters, regardless of the severity, will be recorded during the trial to assess the safety of PNS.Conclusions: To our knowledge, this study is the first double-blind trial to assess the efficacy and safety of PNS in patients with AIS. Findings of the EXPECT trial will be valuable in improving evidence regarding the clinical application of PNS therapy in patients with AIS ineligible for revascularization treatment in the reperfusion era.

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Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial

BMC Neurology ◽

10.1186/s12883-020-01844-8 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Jun Ni ◽

◽

Huisheng Chen ◽

Guofang Chen ◽

Yong Ji ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Controlled Trial ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo

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Safety and Efficacy of Thrombolytic Therapy Using rt-PA (Alteplase) in Acute Ischemic Stroke

ISRN Neurology ◽

10.5402/2011/618624 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Palanisamy Sivanandy ◽

Binny Thomas ◽

Vijayan Krishnan ◽

Sumathy Arunachalam

Keyword(s):

Ischemic Stroke ◽

Thrombolytic Therapy ◽

Acute Ischemic Stroke ◽

Efficacy And Safety ◽

Safety And Efficacy

The aim of this study was to evaluate the efficacy and safety of thrombolytic therapy. Our study enrolled 23 patients out of which 2 patients died due to ICH; we also found that only 39% of patients reached hospital within stroke window, and for those treated, mean NIHSS during admission was 14.0, but drastic improvement was shown after 24 hours of treatment, that is, 9.89 (), and at discharge, it was 5.1 () which showed a clear impact of the treatment, and around 60% of patients were discharged within an mRS score of 1 and 2. Hence, it was found that thrombolytic therapy was beneficial, efficacious, and safe if used within 3 to 4.5 hours.

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Abstract WP96: The Efficacy and Safety of HT047 in Patients With Acute Ischemic Stroke: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase II Trial

Stroke ◽

10.1161/str.51.suppl_1.wp96 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Sung Hyuk Heo ◽

Bum Joon Kim ◽

Dae-Il Chang ◽

Hye-Yeon Choi ◽

Young Seo Kim ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Low Dose ◽

Phase Ii Trial ◽

Study Groups ◽

High Dose ◽

Motor Score ◽

Double Blind ◽

Double Blind Placebo ◽

Parallel Group

Introduction: HT047 is an herbal mixture extract of the Scutellaria baicalensis and Pueraria lobata plants, which have been widely used to treat ischemic stroke in traditional Korean medicine. The aims of this trial are to investigate whether HT047 can improve neurological status, particularly motor function, in acute ischemic stroke patients, and to determine the safety and tolerance of HT047. Methods: In this randomized, double-blind, placebo-controlled, parallel-group, phase II trial, we enrolled patients with acute ischemic stroke within the past 14 days from 8 centers in Korea. The participating patients must have a Fugl-Meyer Assessment (FMA) motor score ≤55 with arm or leg weakness, and Korean version of the National Institutes of Health Stroke Scale (K-NIHSS) score of ≥4 and ≤15. Seventy-eight participants will be randomized in a 1:1:1 ratio and given high-dose HT047 (750 mg three times a day), low-dose HT047 (500 mg three times a day), or a placebo for 12 weeks. The primary endpoint is the change in FMA motor score between baseline and week 12. The trial is registered with ClinicalTrials.gov, NCT02828540. Results: Between Aug, 2016, and Aug, 2018, we randomly assigned 78 patients to one of the three study groups, of whom 66 patients were assessed for the primary endpoint in full analysis set. The median (min, max) changes in FMA motor score of high-dose HT047 and low-dose HT047 were 24 (0, 63) and 43 (-2, 70) (placebo group=28 [0, 63], p=0.929 and p=0.705, respectively). The prevalence of favorable outcome defined as modified Rankin scale score of 0-2 were 47.6% (p=0.919) in high-dose HT047 group and 57.1% (p=0.106) in low-dose HT047 group (31.6% in placebo group). Adverse events were similar across the three study groups. Conclusions: This study is a first-in-human trial of HT047, and there were no between-group differences on the primary and secondary endpoints.

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