Efficiency of Enrollment in a Successful Phase II Acute Stroke Clinical Trial (original) (raw)
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Does Study Enrollment Delay Treatment With Intravenous Thrombolytics for Acute Ischemic Stroke?
Stroke, 2009
Background and Purpose-Enrollment in acute stroke trials at a stroke center with multiple study protocols may delay the initiation of intravenous thrombolytics in patients who present within 3 hours of symptom onset. Methods-We studied all patients presenting with acute ischemic stroke over the past 3.5 years who qualified for thrombolysis within 3 hours of symptom onset. We collected demographics, baseline National Institutes of Health Stroke Scale scores, CT findings, and arrival-to-treatment times and compared patients treated with intravenous thrombolytics in a clinical trial with patients who received standard of care intravenous tissue plasminogen activator. Results-Of 290 treated patients, 19 were enrolled in prelytic studies, 46 were enrolled in postlytic studies, and 225 were treated with standard intravenous tissue plasminogen activator. There was no significant difference in age, gender, National Institutes of Health Stroke Scale score, admission glucose, or changes on CT. There was no difference in onset-to-arrival time or arrival-to-treatment time between patients enrolled in clinical studies and those who received standard treatment. However, among study patients, prelytic randomization led to a significantly longer arrival-totreatment time by 13 minutes (Pϭ0.028). Conclusion-We found that trials requiring prethrombolytic randomization can lead to a delay in the initiation of treatment. Future studies are needed to determine if such a delay is clinically significant and can be shortened by improved enrollment strategies. (Stroke. 2009;40:663-665.)
Stroke; a journal of cerebral circulation, 2012
The publication of the European Cooperative Acute Stroke Study (ECASS III) expanded the treatment time to thrombolysis for acute ischemic stroke from 3 to 4.5 hours from symptom onset. The impact of the expanded time window on treatment rates has not been comprehensively evaluated in a population-based study. All patients with an ischemic stroke presenting to an emergency department during calendar year 2005 in the 17 hospitals that compromise the large 1.3 million Greater Cincinnati/Northern Kentucky population were included in the analysis. Criteria for exclusion from thrombolytic therapy are analyzed retrospectively for both the standard and expanded timeframes with varying door-to-needle times. During the study period, 1838 ischemic strokes presenting to an emergency department were identified. A small proportion of them arrived in the expanded time window (3.4%) compared with the standard time window (22%). Only 0.5% of those who arrived in this timeframe met eligibility criter...
Stroke, 2004
Background and Purpose-Acute ischemic stroke patients are infrequently treated with recombinant tissue plasminogen activator (rtPA). We present unique population-based data regarding the eligibility of ischemic stroke patients for rtPA treatment. Methods-All ischemic strokes presenting to an emergency department (ED) within a biracial population of 1.3 million were identified. The patient was considered eligible for rtPA on the basis of exclusion criteria from the National Institute of Neurological Disorders and Stroke rtPA trial. Results-Of 2308 ischemic strokes, 1849 presented to an ED. Only 22% of all ischemic strokes in the population arrived in the ED in Ͻ3 hours from symptom onset; of these, 209 (51%) were ineligible for rtPA on the basis of mild stroke severity, medical and surgical history, or blood tests.
International Journal of Environmental Research and Public Health
Ischemic stroke is the most common type of stroke, and early interventional treatment is associated with favorable outcomes. In the guidelines, thrombolytic therapy using recombinant tissue-type plasminogen activator (rt-PA) is recommended for eligible patients with acute ischemic stroke. However, the risk of hemorrhagic complications limits the use of rt-PA, and the risk factors for poor treatment outcomes need to be identified. To identify the risk factors associated with in-hospital poor outcomes in patients treated with rt-PA, we analyzed the electronic medical records of patients who were diagnosed with acute ischemic stroke and treated for rt-PA at Chang Gung Memorial Hospitals from 2006 to 2016. In-hospital death, intensive care unit (ICU) stay, or prolonged hospitalization were defined as unfavorable treatment outcomes. Medical history variables and laboratory test results were considered variables of interest to determine risk factors. Among 643 eligible patients, 537 (83.5...
Neurology Research International
Background. Intravenous recombinant tissue plasminogen activator (i.v. rt-PA) is the milestone treatment for patients with acute ischemic stroke. Stroke Fast Track (SFT) facilitates time reduction, guarantees safety, and promotes good clinical outcomes in i.v. rt-PA treatment. Nursing case management is a healthcare service providing clinical benefits in many specific diseases. The knowledge about the efficacy of a nurse case management for Stroke Fast Track is limited. We aim to study the effect of nurse case management on clinical outcomes in patients with acute ischemic stroke involving intravenous recombinant tissue plasminogen activator (i.v. rt-PA) treatment. Methods. Seventy-six patients with acute ischemic stroke who received i.v. rt-PA treatment under Stroke Fast Track protocol of Thammasat University Hospital were randomized into two groups. One group was assigned to get standard care (control) while another group was assigned to get standard care under a nurse case manage...
Eligibility for Recombinant Tissue Plasminogen Activator in Acute Ischemic Stroke
Cerebrovascular Diseases, 2006
Background and Purpose-Acute ischemic stroke patients are infrequently treated with recombinant tissue plasminogen activator (rtPA). We present unique population-based data regarding the eligibility of ischemic stroke patients for rtPA treatment. Methods-All ischemic strokes presenting to an emergency department (ED) within a biracial population of 1.3 million were identified. The patient was considered eligible for rtPA on the basis of exclusion criteria from the National Institute of Neurological Disorders and Stroke rtPA trial. Results-Of 2308 ischemic strokes, 1849 presented to an ED. Only 22% of all ischemic strokes in the population arrived in the ED in Ͻ3 hours from symptom onset; of these, 209 (51%) were ineligible for rtPA on the basis of mild stroke severity, medical and surgical history, or blood tests.
Journal of Stroke and Cerebrovascular Diseases, 2010
Background-In 1995 two studies by the NINDS showed that intravenous t-PA was superior to placebo in stroke patients when given less than 3 hours from stroke onset. The recently published ECASS III study introduced new patient selection criteria and treatment between 3 and 4.5 hours. Using these criteria, t-PA was shown effective at the later time window. Both analyses used the 3 month mRS as main primary outcome. We sought to study the effect of applying the ECASS III selection criteria to the original NINDS cohort. Methods-We analyzed the subgroup of patients from NINDS sample who matched the ECASSS III study criteria and examined 3-month outcomes adjusted and unadjusted for confounding factors. Results-The NINDS t-PA study included 624 patients. Two hundred in the t-PA treated and 199 in the placebo group were selected after applying ECASS III criteria. Of these selected patients, 52% in the t-PA group versus 31% had an mRS of 0 or 1 at 3 months (p<0.001). The unadjusted OR for t-PA treatment versus placebo on day 90 mRS 0-1 versus 2-6 was 2.45 (95% CI: 1.63-3.69) When adjusted for baseline NIHSS, smoking status, time to treatment and history of hypertension the OR was 2.14 (95% CI: 1.34-3.41) (p<0.001). Conclusion-Using the ECASS III patient selection in patient treated in less than 3 hours, 52% of t-PA treated patient had a favorable outcome at 3 months.
Stroke, 2008
Background and Purpose-Multiple approaches are being studied to enhance the rate of thrombolysis for acute ischemic stroke. Treatment of myocardial infarction with a combination of a reduced-dose fibrinolytic agent and a glycoprotein (GP) IIb/IIIa receptor antagonist has been shown to improve the rate of recanalization versus fibrinolysis alone. The combined approach to lysis utilizing eptifibatide and recombinant tissue-type plasminogen activator (rt-PA) (CLEAR) stroke trial assessed the safety of treating acute ischemic stroke patients within 3 hours of symptom onset with this combination.
Background: In ischemic stroke, administration of tissue plasminogen activator (tPA) within 4.5 hours from the time last known well (LKW) improves outcomes, with better outcomes seen with earlier administration. However, for patients presenting early, a perception of significant remaining time within this window may lead to delayed tPA administration. We hypothesized that cases with a shorter LKW-to-stroke team activation (code) time will have a longer " code-to-tPA " administration time. Methods: In the Mount Sinai Hospital Stroke Registry (2009-2015), 122 patients received tPA. The patients were divided by " LKW-to-code " time into 3 groups: 0-59 minutes (n = 38), 60-119 minutes (n = 49), and 120 minutes or more (n = 35). The code-to-tPA time was compared among these groups, adjusting for age, sex, National Institutes of Health Stroke Scale (NIHSS) score, and race–ethnicity. Results: The average code-to-tPA time was 80 minutes in the 0-59 minutes group, 67 minutes in the 60-119 minutes group, and 52 minutes in the 120 minutes or more group (analysis of variance P < .0001). There was an average 28-minute difference (P = .021) between the 0-59 and 120 minutes or more groups. Conclusion: There was a significant negative correlation between the LKW-to-code time and the code-to-tPA time that was independent of age, sex, NIHSS score, and race–ethnicity. Key Words: Ischemic stroke—cerebrovascular disease—quality improvement— tPA—alteplase.