Evolution of Acute Ischemic Stroke Drug Clinical Trials in Mainland China From 2005 to 2021: A Systematic Review

2021 ◽  
Author(s):  
Chunrui Bo ◽  
Hongyan Li ◽  
Tianqi Wang ◽  
Junwei Hao
Author(s):  
N. Cano-Cuenca ◽  
J. Solís-García del Pozo ◽  
J. Jordán

Background: Citicoline is considered an ingredient in particular foods in the USA and is available in pharmaceutical form in Europe and Japan. It has been postulated to render positive effects on the nervous system, either by increasing levels of neurotransmitters, or by affording neuroprotection. Methods: Several clinical trials have shown the efficacy and safety of this biomolecule in several neurodegenerative diseases and in acute ischemic stroke. Here, we have performed a systematic review to validate the effect of citicoline on MMSE, memory, attention, and basic activity of daily living. In electronic database searches, we found 14 randomized clinical trials reporting citicoline effects on cognitive function. Findings: A positive effect of citicoline on MMSE in acute ischemic stroke was found, which was not evidenced for Alzheimer disease or vascular dementia. On activities of daily living, citicoline failed to exert beneficial effects in patients with acute ischemic stroke or progressive cognitive impairment. Conclusions: Given the present data there is no evidence that supports advising patients with cognitive alterations to take chronic citicoline supplements.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Toshiya Osanai ◽  
Vinary Pasupuleti ◽  
Abhishek Deshpande ◽  
Priyaleela Thota ◽  
Yuani Roman ◽  
...  

Introduction: Endovascular (intra-arterial, IA) therapy for acute ischemic stroke has become part of acute therapy , but limited randomized clinical trials have had inconsistent results. We sought to evaluate efficacy and safety of endovascular therapy in - randomized clinical trials . Methods: We performed a systematic review of literature for randomized clinical trials of endovascular therapy with thrombolytic or mechanical reperfusion compared with comparator groups without IA therapy. Use of systemic thrombolysis was not excluded. Primary outcome was modified Rankin scale of disability of 0-2 at 90 days and secondary outcomes of mortality at 90 days and symptomatic intracranial hemorrhage was noted. Two groups of independent reviewers searched and identified studies and abstracted data. Random-effects meta-analysis was performed. Subgroups were analyzed by study design characteristics. Results: Systematic search identified 10 studies with 1572 subjects, of which 9 studies reported the primary outcome. IA therapy was associated with good outcome at 90 days (Odds ratio (OR) =1.28; 95% CI, 1.01 to 1.62; p=0.04), but there was significant heterogeneity with p of 0.03. Among 3 trials (n=1136) comparing mechanical thrombectomy with control, mechanical thrombectomy was not superior to control with good outcome (OR=0.98; 95 % CI, 0.85 to 1.14; p=0.83). Patients with IA therapy significantly have good outcome in studies without systematic thrombolysis in the comparator (OR=1.55; 95 % CI, 1.05 to 2.29; p=0.03) and required vessel occlusion for randomization (OR=1.54; 95 % CI, 1.10 to 2.14; p=0.01). Mortality was unchanged with IA therapy (OR=0.92; 95 % CI, 0.75 to 1.13; p=0.45) and there was no difference in symptomatic hemorrhage (OR=1.13; 95 % CI, 0.74 to 1.74; p=0.56). Conclusion: IA therapy has a small but significant increase in good outcomes for patients with acute ischemic stroke without increasing mortality and symptomatic hemorrhages.


2020 ◽  
Vol 21 (1) ◽  
pp. 42 ◽  
Author(s):  
Chong Hyun Suh ◽  
Seung Chai Jung ◽  
Byungjun Kim ◽  
Se Jin Cho ◽  
Dong-Cheol Woo ◽  
...  

2022 ◽  
Vol 15 (1) ◽  
Author(s):  
Neha Potla ◽  
Latha Ganti

Abstract Introduction Thrombolysis for acute ischemic stroke (AIS) with alteplase is the currently approved therapy for patients who present within 4.5 h of symptom onset and meet criteria. Recently, there has been interest in the thrombolytic tenecteplase, a modified version of alteplase, due to its lower cost, ease of administration, and studies reporting better outcomes when compared to alteplase. This systematic review compares the efficacy of tenecteplase vs. alteplase with regard to three outcomes: (1) rate of symptomatic hemorrhage, (2) functional outcome at 90 days, and (3) reperfusion grade after thrombectomy to compare the efficacy of both thrombolytics in AIS Methods The search was conducted in August 2021 in PubMed, filtered for randomized controlled trials, and studies in English. The main search term was “tenecteplase for acute stroke.” Results A total of 6 randomized clinical trials including 1675 patients with AIS was included. No one’s study compared alteplase to tenecteplase with all three outcomes after acute ischemic stroke; however, by using a combination of the results, this systematic review summarizes whether tenecteplase outperforms alteplase. Conclusions The available evidence suggests that tenecteplase appears to be a better thrombolytic agent for acute ischemic stroke when compared to alteplase.


2019 ◽  
Vol 24 (5) ◽  
pp. 558-571 ◽  
Author(s):  
Kartik Bhatia ◽  
Hans Kortman ◽  
Christopher Blair ◽  
Geoffrey Parker ◽  
David Brunacci ◽  
...  

OBJECTIVEThe role of mechanical thrombectomy in pediatric acute ischemic stroke is uncertain, despite extensive evidence of benefit in adults. The existing literature consists of several recent small single-arm cohort studies, as well as multiple prior small case series and case reports. Published reports of pediatric cases have increased markedly since 2015, after the publication of the positive trials in adults. The recent AHA/ASA Scientific Statement on this issue was informed predominantly by pre-2015 case reports and identified several knowledge gaps, including how young a child may undergo thrombectomy. A repeat systematic review and meta-analysis is warranted to help guide therapeutic decisions and address gaps in knowledge.METHODSUsing PRISMA-IPD guidelines, the authors performed a systematic review of the literature from 1999 to April 2019 and individual patient data meta-analysis, with 2 independent reviewers. An additional series of 3 cases in adolescent males from one of the authors’ centers was also included. The primary outcomes were the rate of good long-term (mRS score 0–2 at final follow-up) and short-term (reduction in NIHSS score by ≥ 8 points or NIHSS score 0–1 at up to 24 hours post-thrombectomy) neurological outcomes following mechanical thrombectomy for acute ischemic stroke in patients < 18 years of age. The secondary outcome was the rate of successful angiographic recanalization (mTICI score 2b/3).RESULTSThe authors’ review yielded 113 cases of mechanical thrombectomy in 110 pediatric patients. Although complete follow-up data are not available for all patients, 87 of 96 (90.6%) had good long-term neurological outcomes (mRS score 0–2), 55 of 79 (69.6%) had good short-term neurological outcomes, and 86 of 98 (87.8%) had successful angiographic recanalization (mTICI score 2b/3). Death occurred in 2 patients and symptomatic intracranial hemorrhage in 1 patient. Sixteen published thrombectomy cases were identified in children < 5 years of age.CONCLUSIONSMechanical thrombectomy may be considered for acute ischemic stroke due to large vessel occlusion (ICA terminus, M1, basilar artery) in patients aged 1–18 years (Level C evidence; Class IIb recommendation). The existing evidence base is likely affected by selection and publication bias. A prospective multinational registry is recommended as the next investigative step.


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