scholarly journals Corrigendum: Efficacy and Safety of Adherence to dl-3-n-Butylphthalide Treatment in Patients With Non-disabling Minor Stroke and TIA—Analysis From a Nationwide, Multicenter Registry

2021 ◽  
Vol 12 ◽  
Author(s):  
Zefeng Tan ◽  
Yin Zhao ◽  
Wanyong Yang ◽  
Shenwen He ◽  
Yan Ding ◽  
...  
Keyword(s):  
Minor Stroke ◽  
Efficacy And Safety ◽  
Multicenter Registry

Efficacy of Dual Antiplatelet Treatment in Minor stroke or TIA Patients with Multiple Acute Infarctions and Lower Level of Stress Hyperglycemic Marker – A Post-hoc Analysis of a Randomized Control Trial

2020 ◽  
Author(s):  
Yue Suo ◽  
Jing Jing ◽  
Anxin Wang ◽  
Yijun Zhang ◽  
Hongyu Zhou ◽  
...  
Keyword(s):  
Minor Stroke ◽  
Efficacy And Safety ◽  
Antiplatelet Treatment ◽  
Bleeding Events ◽  
Vascular Events ◽  
Stress Hyperglycemia ◽  
Post Hoc Analysis ◽  
Acute Infarction ◽  
Post Hoc ◽  
Dual Antiplatelet Treatment

Abstract Background We intended to investigate how the interaction between glycemic status and infarction pattern affected the efficacy and safety of dual antiplatelet treatment in minor stroke or transient ischemic attack (TIA) patients.Methods This post-hoc analysis of the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) study included 797 patients with complete data of stress hyperglycemia markers (fasting plasma glucose (FPG)/glycated albumin (GA) ratio) and Magnetic Resonance Imaging work-up. The primary outcome is a 90-day new stroke (ischemic or hemorrhagic). Other endpoints included combined vascular events and bleeding events at 90 days. We used multivariable Cox regression models to evaluate the influence of stress hyperglycemia status × infarction pattern (Multiple acute infarctions (MAI), Single acute infarction (SAI) and No acute infarction (NAI)) on the efficacy and safety of clopidogrel plus aspirin treatment.Results Among 797 patients, the median age was 63.1 years, and 64.9% of the patients were male. Within the 90-day after randomization, 73 (9.2%) new strokes 75 (9.4%) combined vascular events, and 17 (2.1%) bleeding events occurred. Dual antiplatelet treatment significantly reduced new stroke and combined vascular events in patients with lower FPG/GA ratio (lower than the median of FPG/GA ratio) and multiple acute infarctions, after adjusted for all potential confounders (11.9% vs. 23.3%, adjusted HR(95% confidence interval, CI): 0.240(0.080–0.713)). No significant reductions of recurrence or occurrence of combined vascular events were seen in the other three groups (NAI or SAI with lower FPG/GA ratio; NAI or SAI with higher FPG/GA ratio and MA with higher FPG/GA ratio). The proportion of bleeding events was similar among treatment groups regardless of the FPG/GA ratio or infarction pattern.Conclusions Clopidogrel plus aspirin treatment was associated with reduced 90-day new stroke or combined vascular events in patients with multiple acute infarctions and lower FPG/GA ratio, without increasing the risk of bleeding events.

Antiplatelet vs. R-tPA for acute mild ischemic stroke: A prospective, random, and open label multi-center study

2019 ◽  
Vol 14 (6) ◽  
pp. 658-663
Author(s):  
Xin-Hong Wang ◽  
Lin Tao ◽  
Zhong-He Zhou ◽  
Xiao-Qiu Li ◽  
Hui-Sheng Chen
Keyword(s):  
Functional Outcome ◽  
Standard Dose ◽  
Intravenous Thrombolysis ◽  
Minor Stroke ◽  
Efficacy And Safety ◽  
Open Label ◽  
Definitive Evidence ◽  
Vascular Stenosis ◽  
Level Of Significance ◽  
Multi Center Study

Rationale The evidence of intravenous thrombolysis in patients with not clearly disabling minor stroke (low National Institutes of Health Stroke Scale of 0–5) is still insufficient. Recent early terminated PRISMS trial could not provide definitive conclusion, although suggesting the similar functional outcome between alteplase and aspirin groups. Recent two clinical trials provide a definitive evidence for the superiority of dual antiplatelet to mono-antiplatelet in minor stroke. However, the efficacy and safety of dual antiplatelet vs. alteplase in the treatment of acute minor stroke are not known. Aim To explore the efficacy and safety of dual antiplatelet with aspirin and clopidogrel vs. alteplase in the treatment of acute minor stroke. Sample size estimates A maximum of 760 subjects are required to test the non-inferiority hypothesis with 80% power according to a one-sided 0.025 level of significance, stratified by age, diabetes, time from onset to treatment, stroke etiology, degree of vascular stenosis, location of index vessel. Methods and design ARAMIS is a prospective, randomized, open label, blinded assessment of endpoints (PROBE) and multicenter clinical trial in China. The subjects are randomized to the control arm (intravenous alteplase with standard dose of 0.9 mg/kg, followed by guideline-based treatment 24 h after thrombolysis) or the experiment arm (clopidogrel: loading dose of 300 mg on the first day, followed by 75 mg daily for 10–14 days; aspirin: 100 mg on the first day, followed by 100 mg daily for 10–14 days; after the combination, antiplatelet will be given based on guideline till 90 days). Study outcome The primary efficacy endpoint is favorable functional outcome, defined as a mRS 0–1 assessed at 90-day post-randomization.

FRI0386 Efficacy and Safety of Off-Label Use of Rituximab in Refractory Lupus: Data from the Italian Multicenter Registry: Table 1.

2014 ◽  
Vol 73 (Suppl 2) ◽  
pp. 527.2-527 ◽  
Author(s):  
L. Iaccarino ◽  
S. De Vita ◽  
G. Ferraccioli ◽  
M. Galeazzi ◽  
R. Gerli ◽  
...  
Keyword(s):  
Efficacy And Safety ◽  
Off Label Use ◽  
Off Label ◽  
Multicenter Registry ◽  
Label Use

scholarly journals Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a parallel, randomised, open-label, multicentre, prospective study

2018 ◽  
Vol 3 (4) ◽  
pp. 263-267 ◽  
Author(s):  
Xiaowen Hou ◽  
Xiaoqiu Li ◽  
Xinhong Wang ◽  
Huisheng Chen
Keyword(s):  
Adverse Events ◽  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Rational Design ◽  
Dual Antiplatelet Therapy ◽  
Prospective Trial ◽  
Minor Stroke ◽  
Efficacy And Safety ◽  
Open Label ◽  
Nihss Score

BackgroundA recent study shows that dual antiplatelet therapy with clopidogrel plus aspirin is superior to aspirin monotherapy for minor stroke, which is defined as a National Institutes of Health Stroke Scale (NIHSS)score of ≤3. However, acute mild-moderate ischaemic stroke (4≤NIHSS≤10) still needs aggressive antiplatelet intervention to prevent deterioration and recurrence of stroke. The efficacy and safety of dual antiplatelet therapy versus aspirin monotherapy in the population are not clear. A multicentre clinical trial is designed to evaluate the efficacy and safety of clopidogrel plus aspirin therapy versus aspirin monotherapy within 48 hours of symptom onset of mild-moderate ischaemic stroke.Methods/DesignThe study is a randomised, open-label, multicentre, prospective trial with a target enrolment of 2700 patients from 60 centres in Northeast China. A treatment allocation identification number to each enrolled patient will be provided by a random number generator. The follow-up time for the clopidogrel plus aspirin and aspirin monotherapy groups is 90 days. The primary efficacy endpoint is a stroke progression event, which is defined as ≥4 point increase in the NIHSS score in 48 hours. The second efficacy endpoints include new ischaemic stroke within 90 days, change in the NIHSS score within 14 days, modified Rankin Scale score on day 90 and other vascular or death events within 90 days. The safety endpoints include mucocutaneous haemorrhage, organ haemorrhage and intracranial haemorrhage, adverse events and severe adverse events. χ2 test, t-test (or Mann-Whitney test), survival analysis and Cox proportional hazards models will be conducted. The findings of the study may provide an important evidence for clinical practice for these patients.DiscussionThe trial will be conducted under a rational design and will provide valuable evidence on the appropriate treatment for this population.Ethics and disseminationThe study was reviewed and approved by the Ethics Committee of the General Hospital of Shen-Yang Military Region (no K(2016) 6).Trial registration numberNCT02869009; Pre-results.

Rationale and design of a Phase 3b, Prospective, Randomized, Open Label, Blinded-endpoint, Multicenter Trial of the Efficacy and Safety of Urokinase Thrombolysis Comparing With Antiplatelet Agents for Patients With Minor Stroke

2021 ◽  
pp. 174749302110143
Author(s):  
Lu Zhao ◽  
Chenyang Jiang ◽  
Yongli Tao ◽  
Yuan Gao ◽  
Yafang Xu ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Sample Size ◽  
Independent Living ◽  
Antiplatelet Agents ◽  
Minor Stroke ◽  
Probe Design ◽  
Type I ◽  
Efficacy And Safety ◽  
Open Label ◽  
Minor Ischemic Stroke

Rationale: Minor ischemic stroke attack has taken a significant part of cerebrovascular disease burden. Benefits of thrombolysis in minor stroke is under debates and the use of urokinase in developing countries needs to be further explored. Aim: TRUST (ThRombolysis of Urokinase for minor STroke) trial was designed to evaluate the efficacy and safety of intravenous urokinase for the treatment of acute minor ischemic stroke. Sample size estimates: To reach a double-sided type I error rate of 0.05 to test our hypothesis, with β=0.80, sample size of 1002 subjects were determined after further adjustment to account for up to 5% nonadherence. Methods and design: TRUST trial was developed with PROBE design, as a multicenter, randomized, open label, single-blind clinical trial with the stage of phase 3b. Study outcomes: The proportion of patients retaining full ability of independent living, which is defined as patients scoring 0-1 on modified Rankin Scale score at 90 days. Discussion: TRUST trial may potentially provide promising and affordable thrombolysis for acute minor ischemic stroke in the developing parts of the world.

Abstract TMP20: Efficacy and Safety of Ticagrelor in Relation to Prior Aspirin Usage in the SOCRATES Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
K.S. L Wong ◽  
Pierre Amarenco ◽  
Gregory W Albers ◽  
Hans Denison ◽  
J D Easton ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Dual Antiplatelet Therapy ◽  
Minor Stroke ◽  
Loading Dose ◽  
Vascular Risk ◽  
Efficacy And Safety ◽  
Significant Treatment ◽  
Group A ◽  
Ischemic Attack ◽  
Aspirin Group

Background: In the SOCRATES study (NCT01994720), addition of ticagrelor to patients on aspirin treatment before randomization may confer the effect of dual antiplatelet therapy as the antiplatelet effect of aspirin persists for more than a week. We aimed to explore safety and efficacy of ticagrelor in this pre-specified group of patients who had received aspirin prior to randomization. Methods: We randomized 13,199 patients with a non-cardioembolic, non-severe ischemic stroke or high-risk transient ischemic attack (TIA) to ticagrelor (180mg loading dose on day 1 followed by 90mg twice daily for days 2-90) or aspirin (300mg on day 1 followed by 100mg daily for days 2-90) within 24 hours of symptom onset. The prior aspirin group consisted of patients who had received aspirin within 7 days before randomization. The primary endpoint was the time to the occurrence of stroke, myocardial infarction, or death within 90 days. Results: The 4,232 patients with prior aspirin usage were older, had more vascular risk factors and vascular disease than the 8,967 patients with no prior aspirin usage. In the prior aspirin group, a primary endpoint occurred in 138/2,130 (6.5%) patients randomized to ticagrelor and in 177/2,102 (8.3%) patients randomized to aspirin (HR 0.76; 95% CI, 0.61-0.95, P=0.016) while for the non-aspirin group in 304/4,459 (6.9%) patients randomized to ticagrelor and in 320/4,508 (7.1%) patients randomized to aspirin (HR 0.96; 95%CI, 0.82-1.12, P=0.59). There was no significant treatment-by-prior-aspirin interaction (P=0.098). Major bleeding occurred in 0.7% of patients randomized to ticagrelor and in 0.4% randomized to aspirin (HR 1.58; 95% CI 0.68-3.65, P=0.28) in the prior aspirin group. Conclusion: In this pre-specified exploratory analysis, ticagrelor showed a numerically greater treatment effect over aspirin in patients taking prior aspirin, although the interaction for treatment by prior aspirin was not statistically significant. Further study is needed to evaluate the combination of ticagrelor and aspirin in patients with minor stroke/TIA.

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