Recanalization within One Hour after Intravenous Tissue Plasminogen Activator Is Associated with Favorable Outcome in Acute Stroke Patients

2010 ◽  
Vol 63 (6) ◽  
pp. 331-336 ◽  
Author(s):  
Kazumi Kimura ◽  
Yasuyuki Iguchi ◽  
Kensaku Shibazaki ◽  
Junya Aoki ◽  
Masao Watanabe ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Favorable Outcome ◽  
Stroke Patients ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen

The randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator in acute stroke with ICA and M1 occlusion (SKIP study)

2019 ◽  
Vol 14 (7) ◽  
pp. 752-755 ◽  
Author(s):  
Kentaro Suzuki ◽  
Kazumi Kimura ◽  
Masataka Takeuchi ◽  
Masafumi Morimoto ◽  
Ryuzaburo Kanazawa ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Endovascular Therapy ◽  
Randomized Study ◽  
Intravenous Thrombolysis ◽  
Stroke Patients ◽  
Bridging Therapy ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen

Rationale Bridging therapy with endovascular therapy (EVT) and intravenous thrombolysis (IVT) has been reported to improve outcomes for acute stroke patients with large-vessel occlusion in the anterior circulation. While the IVT may increase the reperfusion rate, the risk of hemorrhagic complications increases. Whether EVT without IVT (direct EVT) is equally effective as bridging therapy in acute stroke remains unclear. Aim This randomized study of endovascular therapy with versus without intravenous tissue plasminogen activator for acute stroke with ICA and M1 occlusion aims to clarify the efficacy and safety of direct EVT compared with bridging therapy. Methods and design This is an investigator-initiated, multicenter, prospective, randomized, open-treatment, blinded-endpoint clinical trial. The target patient number is 200, comprising 100 patients receiving direct EVT and 100 receiving bridging therapy. Study outcome The primary efficacy endpoint is a modified Rankin Scale score of 0–2 at 90 days. Safety outcome measures are any intracranial hemorrhage at 24 h. Discussion This trial may help determine whether direct EVT should be recommended as a routine clinical strategy for ischemic stroke patients within 4.5 h from onset. Direct EVT would then become the choice of therapy in stroke centers with endovascular facilities. Trial registration UMIN000021488.

Abstract W P63: Comparison of the Efficacy and Safety of the Acute Stroke Patients Receiving Different Dose Intravenous Tissue Plasminogen Activator

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Xiaoling Liao ◽  
Yilong Wang ◽  
Yuesong Pan ◽  
Chunjuan Wang ◽  
Xingquan Zhao ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Standard Dose ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Stroke Patients ◽  
Intravenous Tissue Plasminogen Activator ◽  
Tissue Plasminogen ◽  
Intravenous Alteplase

Background and Purpose: In consideration of the racial differences, distinctly reduced cost of treatment and anticipated lower rates of symptomatic intracranial hemorrhage(SICH) coupled with the comparable efficacy, many Asian centers adopted the low dose intravenous tissue plasminogen activator (tPA). We aimed to examine whether lower dose tPA is comparable to standard dose by comparing the efficacy and safety of different doses of tPA in Chinese acute stroke patients. Methods: We analyzed data from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China(TIMS-China)- a prospective, multicentric cohort study of intravenous alteplase treatment with patient enrollment from 67 centres across China. Patients who were fully compliant with Chinese product characteristics criteria of alteplase within 4.5 h after symptom onset were included. And these patients were divided into 5 group according to dose regimens of tPA (<0.5, 0.5-0.7, 0.7-0.85 , 0.85-0.95 and >=0.95 mg/kg). The SICH, mortality and 90-day outcome of patients were compared. Results: A total of 919 patients were included (<0.5 n=9, 0.5-0.7 n=75, 0.7-0.85 n=131, 0.85-0.95 n=678,and >=0.95 n=26). In consideration of sample size, only 0.5-0.7, 0.7-0.85 and 0.85-0.95 mg/kg group were compared. Median tPA dose were 0.90, 0.79 and 0.64mg/kg.Median Stroke onset to treatment time were 2.79h,2.86h and 2.90h (p=0.941). Median NIHSS score were 11,10 and 10(p=0.252). After adjustment for the baseline variables, there were no significant differences for mortality(5.41% vs 8.66% vs 7.36%, p=0.695) and SICH(0% vs 3.82% vs 1.46%, p=0.106). For excellent recovery outcome defined as modified Ranking Scale(mRS) 0-1 at 3 month, 0.5-0.7 mg/kg group were significantly worse than 0.85-0.95 mg/kg group(OR=0.58,p=0.031). For functional independence outcome defined as mRS 0-2 at 3 month, 0.70-0.85 mg/kg group were significantly worse than 0.85-0.95 mg/kg group(OR=0.66,p=0.036) Conclusion: Our study suggests that stoke patients receiving standard dose tPA may have more favorable outcome than those receiving lower dose tPA. For Asian people, 0.9mg/kg is also the most optimal dose for intravenous alteplase treatment.

Abstract T P66: Safety and Effectiveness of Intravenous Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke Patients on Aspirin and Clopidogrel

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Mushtaq H Qureshi ◽  
Shayaan M Khan ◽  
Nauman Jahangir ◽  
Ahmed A Malik ◽  
Melissa Freese ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Combination Therapy ◽  
Acute Ischemic Stroke ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Recombinant Tissue Plasminogen Activator ◽  
Favorable Outcome ◽  
Stroke Patients ◽  
Neurological Improvement ◽  
Tissue Plasminogen

Background: The number of acute ischemic stroke patients who are on both aspirin and clopidogrel treatment at time of acute ischemic event is increasing. There is limited data regarding the safety and efficacy of intravenous recombinant tissue plasminogen activator (rt-PA) treatment in such patients. Methods: We reviewed the medical records and imaging data of consecutive patients with acute ischemic stroke who received IV rt-PA within 4.5 hours of symptom onset. We stratified the patients based on active regular use of antiplatelet medications: monotherapy (aspirin or clopidogrel), combination therapy (aspirin and clopidogrel), and no therapy and compared the rates of symptomatic intracerebral hemorrhage (ICH), neurological improvement (≥4 points in National Institutes of Health Stroke Scale [NIHSS], and favorable outcome (modified Rankin scale [mRS] 0-1) at discharge between the three groups. Results: A total of 88 acute ischemic stroke patients (mean age±SD; 69.88 ±15) were treated with IV rt-PA within the study duration. Of the 88 patients 45 (50.6%), 37 (41.6%), and 52 (58.4) were on monotherapy, combination therapy, or no therapy at time of presentation. The proportion of patients who developed symptomatic ICHs were similar (p=0.8) in monotherapy, combination therapy, and no therapy groups (3.3%, 0.0%, and 4.1%, respectively). The rates of neurological improvement were greater in patients on monotherapy (20%) (p=0.03) followed by combination therapy (11.1%), and no therapy groups (2.0%). There was no significant reduction in the rate of favorable outcome at discharge among patients on combination treatment compared with no treatment (odds ratio 0.8 , 95% confidence interval 0.4-1.8 ) after adjusting for age and initial NIHSS score strata (<10, 10-19, and ≥20). Conclusions: Compared with patients on no antiplatelet treatment, acute ischemic stroke patients who are actively using aspirin and clopidogrel appear to have similar risks and benefits with IV rt-PA treatment.

ERic Acute StrokE Recanalization: A study using predictive analytics to assess a new device for mechanical thrombectomy

2017 ◽  
Vol 12 (6) ◽  
pp. 659-666 ◽  
Author(s):  
Susanne Siemonsen ◽  
Nils D Forkert ◽  
Martina Bernhardt ◽  
Götz Thomalla ◽  
Martin Bendszus ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Stroke ◽  
Acute Ischemic Stroke ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Trial Design ◽  
Mechanical Thrombectomy ◽  
Predictive Analytics ◽  
Stroke Patients ◽  
Tissue Plasminogen

Aim and hypothesis Using a new study design, we investigate whether next-generation mechanical thrombectomy devices improve clinical outcomes in ischemic stroke patients. We hypothesize that this new methodology is superior to intravenous tissue plasminogen activator therapy alone. Methods and design ERic Acute StrokE Recanalization is an investigator-initiated prospective single-arm, multicenter, controlled, open label study to compare the safety and effectiveness of a new recanalization device and distal access catheter in acute ischemic stroke patients with symptoms attributable to acute ischemic stroke and vessel occlusion of the internal cerebral artery or middle cerebral artery. Study outcome The primary effectiveness endpoint is the volume of saved tissue. Volume of saved tissue is defined as difference of the actual infarct volume and the brain volume that is predicted to develop infarction by using an optimized high-level machine learning model that is trained on data from a historical cohort treated with IV tissue plasminogen activator. Sample size estimates Based on own preliminary data, 45 patients fulfilling all inclusion criteria need to complete the study to show an efficacy >38% with a power of 80% and a one-sided alpha error risk of 0.05 (based on a one sample t-test). Discussion ERic Acute StrokE Recanalization is the first prospective study in interventional stroke therapy to use predictive analytics as primary and secondary endpoint. Such trial design cannot replace randomized controlled trials with clinical endpoints. However, ERic Acute StrokE Recanalization could serve as an exemplary trial design for evaluating nonpivotal neurovascular interventions.

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