Clinical Efficacy of Cerebrolysin and Cerebrolysin plus Nootropics in the Treatment of Patients with Acute Ischemic Stroke in Vietnam

Aims: To investigate the efficacy and safety of Cerebrolysin and Cerebrolysin plus nootropics in the routine treatment of patients with acute ischemic stroke (AIS). Background: Acute ischemic stroke (AIS) is a leading cause of disability with unmet treatment needs lacking effective drug therapy. Multimodal drugs modulating stroke pathophysiology as Cerebrolysin constitute a good therapeutic option. Objective: In this study, we assessed the effects of Cerebrolysin and Cerebrolysin plus nootropics, in comparison with other nootropic drugs alone, on functional, neurological and cognitive recovery of patients with AIS in Vietnam. Methods.: This non-interventional, controlled, open-label, prospective and multicenter study included 398 AIS patients (234 males) treated with Cerebrolysin (n=190; 20 i.v. infusions of 10 ml), other nootropics (comparator group; n=86), or a combination of both (n=122). The study primary endpoint was a modified Ranking Scale (mRS) score on day 90. Secondary endpoints included study-period change in NIHSS score; percentage of well-recovered (mRS 0-2) patients, the proportion of good NIHSS response (≥6 points) cases, and MoCA scores at day 90; and safety indicators. Results: Compared with other nootropics, both Cerebrolysin and combined therapy induced significant improvements (p<0.001) in: Functional recovery (mRS scores); percentage of well-recovered patients (Cerebrolysin: 81.6%; combination: 93.4%; comparator: 43.0%); neurological recovery (study-period NIHSS change); proportion of good NIHSS responders (Cerebrolysin: 77.5%; combination: 92.5%; comparator: 47.6%); and MoCA scores (Cerebrolysin: 23.3±4.8; combination: 23.7±4.1; comparator: 15.9±7.7). Compared to Cerebrolysin, combined therapy improved (p<0.01) mRS outcomes and NIHSS change, but not MoCA scores, in moderate-severe stroke (NIHSS>11) cases only. No drug-related adverse events were reported. Conclusion: Cerebrolysin alone or combined with other nootropics was effective and safe in routine AIS treatment, during both acute and recovery phases, which supports its use in daily clinical practice. Other: According to the results of this multicenter study, the importance of reducing differences in the treatment regimens of AIS in Vietnam should be further emphasized.

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Restoration of early deficiency of axonal guidance signaling by guanxinning injection as a novel therapeutic option for acute ischemic stroke

Pharmacological Research ◽

10.1016/j.phrs.2021.105460 ◽

2021 ◽

pp. 105460

Author(s):

Guangxu Xiao ◽

Ming Lyu ◽

Zhixiong Li ◽

Linghua Cao ◽

Xinyan Liu ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Therapeutic Option ◽

Axonal Guidance ◽

Novel Therapeutic

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Abstract P104: Incidence, Characteristics and Outcomes of Large Vessel Stroke in Covid-19: An International Multicenter Study

Stroke ◽

10.1161/str.52.suppl_1.p104 ◽

2021 ◽

Vol 52 (Suppl_1) ◽

Author(s):

Priyank Khandelwal ◽

Fawaz Al-Mufti ◽

Ambooj Tiwari ◽

Amit Singla ◽

Adam A Dmytriw ◽

...

Keyword(s):

Ischemic Stroke ◽

African Americans ◽

Acute Ischemic Stroke ◽

Multicenter Study ◽

Significant Risk ◽

Large Vessel ◽

Large Vessel Occlusion ◽

Vessel Occlusion ◽

International Multicenter Study ◽

International Multicenter

Background: While there are reports of acute ischemic stroke (AIS) in COVID-19 patients, the overall incidence of acute ischemic stroke and clinical characteristics of large vessel occlusion in such patient remains to be established. Methods: A retrospective, international multicenter study of large vessel occlusion (LVO) was undertaken from March 1 to May 1, 2020 at 12 stroke centers from 4 countries. Detailed data were collected on consecutive LVOs in hospitalized patients with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the incidence of AIS/LVO was measured. Among patients who underwent mechanical thrombectomy, stroke outcomes along with COVID-19 symptoms were reported. Results: Out of a total of 6698 COVID-19 patients admitted to 10 stroke centers, the incidence of stroke was found to be 1.3% (range 0.6-2.6%). The median age of patients who presented with LVO was 51 years (range 27-87) and in the US centers, African Americans comprised 28% of all patients. Ten patients (16 %) were less than 50 years of age with no significant risk factors for LVOs the vast majority. Among the LVOs eligible for MT, the average time to presentation from symptom onset to presentation was 9.3 hours. Successful revascularization was achieved in 81% of patients and the intracranial hemorrhage rate was 14% with no symptomatic hemorrhages. Twenty-one (50%) patients were either discharged to home or to acute rehabilitation facilities. Conclusion: LVOs was predominant in patients with AIS and COVID-19, occurring at a significantly younger age and affecting African Americans disproportionately.

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CT perfusion-guided patient selection for endovascular recanalization in acute ischemic stroke: a multicenter study

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2012-010491 ◽

2012 ◽

Vol 5 (6) ◽

pp. 523-527 ◽

Cited By ~ 43

Author(s):

Aquilla S Turk ◽

Jordan Asher Magarick ◽

Don Frei ◽

Kyle Michael Fargen ◽

Imran Chaudry ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Patient Selection ◽

Multicenter Study ◽

Ct Perfusion ◽

Endovascular Recanalization ◽

Selection For

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Abstract TMP25: Effects of Age and Ethnicity on the Benefits and Risks of Low- versus Standard-dose Alteplase in Acute Ischemic Stroke Patients: The Enchanted Trial

Stroke ◽

10.1161/str.48.suppl_1.tmp25 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Xia Wang ◽

Thompson Robinson ◽

Hisatomi. Arima ◽

Joseph Broderick ◽

Andrew Demchuk ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Treatment Effects ◽

Low Dose ◽

Standard Dose ◽

Intravenous Thrombolysis ◽

Open Label ◽

Poor Outcome ◽

Symptomatic Intracerebral Hemorrhage ◽

Stroke Study

Background and Purpose: As lower doses of alteplase reduce the risk of symptomatic intracerebral hemorrhage (sICH), older and Asian people may benefit more from low-dose alteplase than other patients with acute ischemic stroke (AIS). Methods: Data from the ENhanced Control of Hypertension ANd Thrombolysis strokE study (ENCHANTED), an international, multi-center, prospective, randomized, open-label, blinded-endpoint trial, were analyzed to assess effects of low- (0.6mg/kg body weight) vs. standard-dose (0.9mg/kg) alteplase in AIS patients, by age and ethnicity (Asian vs. non-Asian), pre-specified subgroup analyses, on key efficacy and safety outcomes. Results: 3297 patients (1248 female), mean age 67 years were included. After adjusting for baseline characteristics and management variables over the first seven days, increasing age was associated with poor outcome, defined by ordinal analysis of the modified Rankin score (mRS) (shift to a less favorable outcome, P trend <0.0001). In the comparison between low- and standard-dose alteplase, no significant differences were observed for 90-day poor outcome by age deciles and ethnicity. Less sICH was observed with low-dose alteplase, and this was consistent for age and ethnicity. There was no ethnic difference in the treatment effects by age, severity, and time to treatment. Conclusions: Increasing age predicts poor outcome in thrombolysis-treated AIS patients. There was no heterogeneity in the treatment effects of low- vs. standard-dose alteplase. Decisions about intravenous thrombolysis should be based on variables other than age and ethnicity.

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Abstract 3314: The Role of Bridging with Intravenous Thrombolysis in Endovascular Therapy of Acute Ischemic Stroke.

Stroke ◽

10.1161/str.43.suppl_1.a3314 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Omar Kass-Hout ◽

Tareq Kass-Hout ◽

Maxim Mokin ◽

David Orion ◽

Shadi Jahshan ◽

...

Keyword(s):

Ischemic Stroke ◽

Endovascular Treatment ◽

Acute Ischemic Stroke ◽

Endovascular Therapy ◽

Combined Therapy ◽

Large Vessel ◽

P Value ◽

Large Vessel Occlusion ◽

Vessel Occlusion ◽

Nihss Score

Background: Large vessel occlusions with a high clot burden are less likely to improve with the FDA-approved IV strategy. Endovascular therapy within the first 3 h of stroke symptom onset provides an effective alternative treatment in patients with large vessel occlusion. It is not clear if combination of IV thrombolysis and endovascular approach is superior to endovascular treatment alone. Methods: We retrospectively reviewed all cases of acute ischemic stroke with large vessel occlusion treated within the first 3 h stroke onset during the 2005-2010 period. First group received endovascular therapy within the first 3 h of stroke onset. Second group consisted of patients who received IV thrombolysis within the first 3 h followed by endovascular therapy. We compared the following outcomes: revascularization rates, NIHSS score at discharge, mRS at discharge and 3months, symptomatic hemorrhage rates and mortality. Results: Among 104 patients identified, 42 received combined therapy, and 62 received endovascular therapy only. The two groups had similar demographic (age and sex distribution) and vascular risk factors distribution, as well as NIHSS score on admission (14.8±4.7 and 16.0±5.3; p=0.23). We found no difference in TIMI recanalization rates (Thrombolysis in Myocardial Infarction scale score of 2 or 3) following combined or endovascular therapy alone (83.3% and 79.0%; p=0.59). A preferred outcome, defined as a mRS of 2 or less at 90 days also did not differ between the combined therapy group and the endovascular only group (37.5% and 34.5%; p=0.76). There was no difference in mortality rate (22.5% and 31.0%; p=0.36) and the rate of symptomatic intracranial hemorrhage (9.5% and 8.1%; p=0.73). There was a significant difference in mean time from symptom onset to endovascular treatment between the combined group (227±88 min) and endovascular only group (125±40 min; p<0.0001).Patients with good TIMI recanalization rate of 2 or 3 showed a trend of having a better mRS at 90 days in both bridging (16.67% vs. 41.18%, p-value: 0.3813) and endovascular groups (25% vs. 34.78%, p-value: 0.7326).When analyzing the correlation of mRS at 90 days with the site of occlusion, patients in the bridging group showed a trend of a better outcome when the site of occlusion was ICA (33.3% vs 30%) and MCA (66.67% vs. 27.59%) and worse outcome when the site of occlusion was in the posterior circulation (26.32% vs. 50%), however, these results were not statistically significant (p-values: 0.1735& 0.5366). Conclusion: Combining IV thrombolysis and endovascular therapy achieves similar rates of clinical outcomes, revascularization rates, complications and mortality rates, when compared with endovascular treatment alone. The combined therapy, however, significantly delays initiation of endovascular treatment. A randomized prospective trial comparing both treatment strategies in acute ischemic stroke is warranted

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Efficacy and Safety of Intravenous Tenecteplase Bolus in Acute Ischemic Stroke: Results of Two Open-Label, Multicenter Trials

American Journal of Cardiovascular Drugs ◽

10.1007/s40256-018-0284-1 ◽

2018 ◽

Vol 18 (5) ◽

pp. 387-395 ◽

Cited By ~ 7

Author(s):

Tirppur C. R. Ramakrishnan ◽

◽

Somasundaram Kumaravelu ◽

Sunil K. Narayan ◽

Sai S. Buddha ◽

...

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Efficacy And Safety ◽

Open Label ◽

Multicenter Trials

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Authors’ Reply to Rana et al. “Efficacy and Safety of Intravenous Tenecteplase Bolus in Acute Ischemic Stroke: Results of Two Open-Label, Multicenter Trials”

American Journal of Cardiovascular Drugs ◽

10.1007/s40256-019-00334-8 ◽

2019 ◽

Vol 19 (2) ◽

pp. 223-224 ◽

Cited By ~ 1

Author(s):

Usha K. Misra ◽

Jayantee Kalita ◽

Mritunjai Kumar ◽

Methil Pradeep

Keyword(s):

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Efficacy And Safety ◽

Open Label ◽

Multicenter Trials

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Enoxaparin Versus Unfractionated Heparin in the Prevention of Venous Thromboembolism After Acute Ischemic Stroke: Rationale, Design, and Methods of an Open-Label, Randomized, Parallel-Group Multicenter Trial

Journal of Stroke and Cerebrovascular Diseases ◽

10.1016/j.jstrokecerebrovasdis.2004.12.008 ◽

2005 ◽

Vol 14 (3) ◽

pp. 95-100 ◽

Cited By ~ 5

Author(s):

David G. Sherman ◽

Sandor Soltes ◽

Rita Samuel ◽

Daniela Chibedi-Deroche

Keyword(s):

Ischemic Stroke ◽

Venous Thromboembolism ◽

Unfractionated Heparin ◽

Acute Ischemic Stroke ◽

Multicenter Trial ◽

Open Label ◽

Parallel Group ◽

Design And Methods

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Intra-arterial Reteplase and Intravenous Abciximab in Patients with Acute Ischemic Stroke: An Open-label, Dose-ranging, Phase I Study

Neurosurgery ◽

10.1227/01.neu.0000232862.06246.3d ◽

2006 ◽

Vol 59 (4) ◽

pp. 789-797 ◽

Cited By ~ 60

Author(s):

Adnan I. Qureshi ◽

Pansy Harris-Lane ◽

Jawad F. Kirmani ◽

Nazli Janjua ◽

Afshin A. Divani ◽

...

Keyword(s):

Ischemic Stroke ◽

Intracerebral Hemorrhage ◽

Acute Ischemic Stroke ◽

Symptom Onset ◽

Favorable Outcome ◽

Platelet Glycoprotein ◽

Open Label ◽

Neurological Improvement ◽

Symptomatic Intracerebral Hemorrhage ◽

Label Dose

Abstract OBJECTIVE: New approaches are focusing on using a combination of medication that lyse fibrin and prevent aggregation of platelets to achieve higher rates of recanalization and improved clinical outcomes. METHODS: A prospective, nonrandomized, open-label trial evaluated the safety of an escalating dose of reteplase in conjunction with intravenous abciximab (platelet glycoprotein IIb/IIIa inhibitor) in patients with acute ischemic stroke (3–6 h after symptom onset). The primary endpoint was symptomatic intracerebral hemorrhage at 24 to 72 hours, and secondary endpoints were partial or complete recanalization (≥ one grade improvement), early neurological improvement (decrease in National Institutes of Health Stroke Scale ≥ 4 at 24 h), and favorable outcome at 1 month (defined by modified Rankin scale ≤ 2). RESULTS: A total of 20 patients (mean age, 65 yr; 13 men) were recruited. Five patients were recruited in each of the escalating tiers of intra-arterial reteplase (0.5, 1, 1.5, and 2 units). Intravenous abciximab (0.25 mg/kg bolus followed by 0.125 μg/kg/min) was successfully administered in 18 out of 20 patients. The safety stopping rule was not activated in any of the tiers. One symptomatic intracerebral hemorrhage was observed in one of the 20 patients (in the 1-unit tier). Partial or complete recanalization was observed in 13 of the 20 patients. Thirteen patients demonstrated early neurological improvement, and favorable outcome at 1 month was observed in six patients. CONCLUSION: In this study, a combination of intra-arterial reteplase and intravenous abciximab was safely administered to patients with ischemic stroke presenting between 3 and 6 hours after symptom onset.

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