Nimodipine in acute ischemic stroke: a double-blind controlled study

In a randomized double-blind placebo-controlled study in 30 patients with acute ischemic stroke, the effect of the adenosine uptake blocker propentofylline on regional brain glucose metabolism (rCMRglu) was investigated using repeated positron emission tomography (PET) with 2-[18F]fluoro-2-deoxy-d-glucose (FDG). Treatment was initiated within 48 h after onset of symptoms. The clinical course was followed for 3 months. In the propentofylline group, after 14 days rCMRglu was increased in the infarct by 37.3% and was practically unchanged in other brain regions, whereas in the control group glucose metabolism had decreased in all regions (1.4–13.4%). These differences were significant between the two groups [Analysis of variance (ANOVA) p = 0.005]. Although there was a trend toward greater clinical improvement in the propentofylline-treated patients, this did not reach statistical significance. The results correspond to experimental data showing that propentofylline improves energy metabolism in cerebral ischemia. A clinical trial is needed to determine whether this new therapeutic principle can be successfully used in acute human stroke.

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Intensive Statin Therapy for Acute Ischemic Stroke to Reduce the Number of Microemboli: A Preliminary, Randomized Controlled Study

European Neurology ◽

10.1159/000494989 ◽

2018 ◽

Vol 80 (3-4) ◽

pp. 163-170 ◽

Cited By ~ 3

Author(s):

Xingyu Chen ◽

Xiaorong Zhuang ◽

Zhongwei Peng ◽

Huili Yang ◽

Liangyi Chen ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Statin Therapy ◽

High Sensitivity ◽

Controlled Study ◽

Statin Group ◽

Pre Treatment ◽

Hs Crp ◽

And Control ◽

Intensive Statin Therapy

Background: To assess whether intensive statin therapy reduces the occurrence of microemboli in patients with acute ischemic stroke. Methods: Patients with acute ischemic stroke within 72 h of onset were randomized to the intensive statin (atorvastatin 60 mg/day, adjusted to 20 mg/day after 7 days) and control (atorvastatin 20 mg/day) groups. Combined aspirin and clopidogrel were used for antiplatelet therapy. Microemboli were monitored by transcranial Doppler on days 1 (pre-treatment), 3, and 7. Metalloproteinase-9 (MMP-9), high-sensitivity C-reactive protein (hs-CRP), and National Institutes of Health Stroke Scale (NIHSS) score were assessed on days 1 and 7. The modified Rankin scale (mRS) was used on day 90. The primary outcome was the proportion of patients with microemboli on day 3. Results: There were 35 (58.3%) and 30 (52.6%) patients with microemboli in the intensive statin (n = 60) and control (n = 57) groups, respectively, on day 1 (p = 0.342). On day 3, there were significantly less microemboli in the intensive statin group (n = 9; 15.0%) compared with controls (n = 16; 28.1%; p = 0.002). No difference was observed in MMP-9 and hs-CRP levels on day 1, but on day 7, MMP-9 (median 79.3 vs. 95.9 μg/L; p = 0.004) and hs-CRP (median 2.01 vs. 3.60 mg/L; p = 0.020) levels were lower in the intensive statin group compared with controls. There were no differences in NIHSS scores on days 1 and 7. There was no difference in mRS on day 90. Conclusion: Intensive atorvastatin therapy in patients with acute ischemic stroke reduces the occurrence of microemboli and inflammation, with no overt adverse events.

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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

10.21203/rs.3.rs-16499/v2 ◽

2020 ◽

Author(s):

Jun Ni ◽

Huisheng Chen ◽

Guofang Chen ◽

Yong Ji ◽

Fei Yi ◽

...

Keyword(s):

Ischemic Stroke ◽

Thrombolytic Therapy ◽

Acute Ischemic Stroke ◽

Barthel Index ◽

Controlled Trial ◽

Survival Rates ◽

Control Group ◽

Efficacy And Safety ◽

Clinical Trial Registry ◽

Double Blind

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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A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke

Stroke ◽

10.1161/strokeaha.109.551382 ◽

2009 ◽

Vol 40 (11) ◽

pp. 3518-3525 ◽

Cited By ~ 23

Author(s):

Philip Teal ◽

Stephen Davis ◽

Werner Hacke ◽

Markku Kaste ◽

Patrick D. Lyden ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Controlled Trial ◽

Double Blind ◽

Double Blind Placebo ◽

Pharmacodynamic Effects

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Olfactory ensheathing cells in chronic ischemic stroke: A phase 2, double-blind, randomized, controlled trial

Journal of Neurorestoratology ◽

10.26599/jnr.2020.9040019 ◽

2020 ◽

Vol 8 (3) ◽

pp. 182-193

Author(s):

Yunliang Wang

Keyword(s):

Ischemic Stroke ◽

Olfactory Ensheathing Cells ◽

Controlled Study ◽

Cell Group ◽

Placebo Control ◽

Phase 2 ◽

Double Blind ◽

Assessment Scores ◽

Ensheathing Cells

Olfactory ensheathing cells (OECs) have shown promising results for patients with neurologic diseases in non-double-blind, placebo control studies. Thirty patients with a unilateral ischemic stroke of more than a year were enrolled in a phase 2, multicenter, randomized, double-blind, and placebo-controlled cell therapy trial with a subsequent 12-month follow-up. The primary therapeutic objective has shown that after 12 months, there were significant differences in National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) and Barthel Index (BI) assessment scores among the OEC group, Schwann cell group and placebo medium group at one-year follow-up. The second therapeutic objective found that there were significant differences in NIHSS, mRS, and BI assessment scores when comparing the endpoint data with the baseline data in the OEC group. There was neither hypersensitivity reaction nor adverse event. The results of this multicenter, randomized, double-blind, and placebo-controlled study indicate that injecting OECs into the olfactory sub-mucosa have neurorestorative effects, which can improve the quality of life for patients with chronic ischemic strokes without serious side effects.

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Association between acute ischemic stroke etiology and macroscopic aspect of retrieved clots: is a clot’s color a warning light for underlying pathologies?

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2019-014905 ◽

2019 ◽

Vol 11 (12) ◽

pp. 1197-1200 ◽

Cited By ~ 2

Author(s):

Alessandro Sgreccia ◽

Zoé Duchmann ◽

Jean Philippe Desilles ◽

Bertrand Lapergue ◽

Julien Labreuche ◽

...

Keyword(s):

Atrial Fibrillation ◽

Ischemic Stroke ◽

Infective Endocarditis ◽

Acute Ischemic Stroke ◽

Mechanical Thrombectomy ◽

Case Reports ◽

Patient Characteristics ◽

Study Groups ◽

Double Blind ◽

Stroke Etiology

BackgroundFew case reports have considered the chromatic aspect of retrieved clots and the possible association with their underlying etiology.ObjectiveThe aim of our study was to analyze the frequency of the TOAST ischemic stroke typical (atrial fibrillation, dissection, atheroma) and atypical (infective endocarditis, cancer-related, valve-related thrombi) etiologies depending on the chromatic aspect of retrieved clots.MethodsA total of 255 anonymized and standardized clot photos of consecutive patients treated by mechanical thrombectomy for acute ischemic stroke were included. A double-blind evaluation was performed by two senior interventional neuroradiologists, who classified the visual aspects of the clots into two main patterns: red/black or white. Main patient characteristics, distribution of underlying stroke etiologies, and outcomes were compared between the two study groups.ResultsThe inter-reader agreement for clot colors was excellent (k=0.78). Two hundred and thirty-three patients were classified as having red/black clots and 22 as having white clots. A statistically significant association (p=0.001) between atypical etiologies and white clots was observed.ConclusionsWhite clots were significantly associated with atypical etiologies in this cohort,in particular, with infectious endocarditis.

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