scholarly journals Emergency Administration of Abciximab for Treatment of Patients With Acute Ischemic Stroke: Results of an International Phase III Trial

Stroke ◽  
2008 ◽  
Vol 39 (1) ◽  
pp. 87-99 ◽  
Author(s):  
Harold P. Adams ◽  
Mark B. Effron ◽  
James Torner ◽  
Antoni Dávalos ◽  
Judith Frayne ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Phase Iii ◽  
Phase Iii Trial

Abstract W P11: Factors Affecting Vascular Neurologists' Decisions to Pursue Endovascular Intervention of Acute Ischemic Stroke Patients

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Amrou Sarraj ◽  
Sheryl Martin-Schild ◽  
Amelia K Boehme ◽  
Emilio P Supsupin ◽  
Clark W Sitton ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Cohort Analysis ◽  
Time Factors ◽  
Phase Iii ◽  
Factors Affecting ◽  
Time Sensitivity ◽  
Retrospective Cohort Analysis ◽  
Phase Iii Trials ◽  
Transferred Patients

Background: Intra-arterial therapy (IAT) is an approach to promote recanalization in acute ischemic stroke (AIS) patients. While IAT continues to go through further evaluation in multiple phase III trials using new devices and focusing on time improvement, patients with LAO continue to be treated with IAT. Multiple clinical, radiographic and time factors go into vascular neurologists’ decisions whether to pursue IAT or not. We aimed to evaluate factors affecting determination of IAT for stroke amongst patients transferred to tertiary centers. Methods: A US multicenter retrospective cohort analysis was conducted on 313 consecutive transferred patients who met vessel criteria from 01/08-4/14. Collateral were measured by the collateral score (CS). ASPECTS decay was defined as a change from good (8-10) to poor (0-7) scores between center CT scans. IAT patients were compared with no IAT patients with regard to factors predictive of IAT. Results: Table 1 shows baseline characteristics of the two groups. Age was not a predictor of IAT. NIHSS was associated with IAT, but was not a predictor of IAT. For each escalating point on CS, the odds of IAT increased more than 4 times (OR 4.27, 95% CI 2.86-7.87, p<0.0001). For each declining point on ASPECTS, the odds of IAT decreased by 22% (OR 0.78, 95% CI 0.72-0.85, p<0.0001). ASPECTS decay was associated with an 83% reduction in the odds of IAT (OR 0.17, 95% CI 0.05-0.52, p<0.0001). For every 30 minutes of time between centers, the odds of ASPECTS decay increased by 13% (OR 1.13, 95% CI 1.11-1.17 p=0.0004) and IAT chances reduced by 9% (OR 0.91, 95% CI 0.84-1.00, p=0.05). Conclusions: Infarction evolution measured by ASPECTS decay, collaterals status and time from stroke ictus are all major determinants of the vascular neurologist decision whether to proceed with IAT. Our findings further support the time-sensitivity of the process for transferring candidates for IAT.

Abstract P148: Safety And Efficacy Of Edaravone Dexborneol Versus Edaravone Alone For The Treatment Of Acute Ischemic Stroke Patients With Hypertention: Analysis From Taste Trial

Hypertension ◽  
2021 ◽  
Vol 78 (Suppl_1) ◽  
Author(s):  
Jie Xu ◽  
Yongjun Wang
Keyword(s):  
Ischemic Stroke ◽  
Adverse Events ◽  
Acute Ischemic Stroke ◽  
Medical History ◽  
Functional Outcomes ◽  
Group Versus ◽  
Phase Iii ◽  
Secondary Outcome ◽  
Serious Adverse Events ◽  
Intention To Treat

Background and Aims: Evidenced by TASTE phase III trial, 90-day good functional outcomes favored the edaravone dexborneol group versus edaravone group when administered within 48 hours after Acute Ischemic Stroke (AIS). The present study aimed to investigate the effects of edaravone dexborneol versus edaravone in AIS patients with hypertension medical history. Methods: This study was a subgroup analysis of the TASTE trial with hypertension medical history. The primary outcome was the proportion of patients with modified Rankin Scale (mRS) score ≤1 on day 90 after randomization. The secondary outcome was the mRS score on day 90. The safety endpoints were the incidences of adverse events, serious adverse events and deaths. Analyses were by intention to treat. Results: We included 767 AIS patients with hypertension (390 in edaravone dexborneol group, 377 in edaravone group) in this analysis. Among them, 252 (64.62%) in edaravone dexborneol group versus 199 (52.79%) in edaravone group reached mRS score ≤1 on D90, revealing significantly higher proportion of mRS score ≤1 on D90 in edaravone dexborneol group (OR 1.63 [95% CI, 1.22-2.18]; P<0.001). Significant differences occurred between two groups in mRS score on D90 ([OR 1.32 [95% CI, 1.02-1.72]; P=0.038). The safety outcomes indicated that the two groups were similar in incidences of adverse events (366 [93.85%] versus 352 [93.37%], p=0.787), serious adverse events (48 [12.31%] versus 34 [9.02%], p=0.1405) and number of deaths (6 [1.54%] versus 4 [1.06%], p=0.56). Conclusion: This analysis demonstrated that AIS patients with hypertension receiving edaravone dexborneol had better functional outcomes than those with edaravone, which provided evidences for the clinical application of edaravone dexborneol in AIS patients with hypertension. Keywords: Edaravone dexborneol, Acute ischemic stroke, Hypertension, mRS score

scholarly journals Therapeutic Hypothermia for Acute Ischemic Stroke: Ready to Start Large Randomized Trials?

2010 ◽  
Vol 30 (6) ◽  
pp. 1079-1093 ◽  
Author(s):  
H Bart van der Worp ◽  
Malcolm R Macleod ◽  
Rainer Kollmar ◽  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Therapeutic Hypothermia ◽  
Animal Studies ◽  
Brain Injuries ◽  
Focal Cerebral Ischemia ◽  
Perinatal Asphyxia ◽  
Phase Iii ◽  
Neuroprotective Strategy ◽  
Critical Issues

Therapeutic hypothermia is a means of neuroprotection well established in the management of acute ischemic brain injuries such as anoxic encephalopathy after cardiac arrest and perinatal asphyxia. As such, it is the only neuroprotective strategy for which there is robust evidence for efficacy. Although there is overwhelming evidence from animal studies that cooling also improves outcome after focal cerebral ischemia, this has not been adequately tested in patients with acute ischemic stroke. There are still some uncertainties about crucial factors relating to the delivery of hypothermia, and the resolution of these would allow improvements in the design of phase III studies in these patients and improvements in the prospects for successful translation. In this study, we discuss critical issues relating first to the targets for therapy including the optimal depth and duration of cooling, second to practical issues including the methods of cooling and the management of shivering, and finally, of factors relating to the design of clinical trials. Consideration of these factors should inform the development of strategies to establish beyond doubt the place of hypothermia in the management of acute ischemic stroke.

scholarly journals Anticoagulation in the early phase of non-valvular atrial fibrillation-related acute ischemic stroke: where do we stand?

2019 ◽  
Vol 13 (1) ◽  
pp. 24-31
Author(s):  
Luca Masotti ◽  
Elisa Grifoni ◽  
Alessandro Dei ◽  
Vieri Vannucchi ◽  
Federico Moroni ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Early Phase ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Real Life ◽  
Stroke Onset ◽  
Phase Iii ◽  
Stroke Recurrence

The balance between the risk of early stroke recurrence and hemorrhagic transformation represents the cornerstone of practical management of non-valvular atrial fibrillation (NVAF)-related acute ischemic stroke (AIS). Patients who receive antithrombotic therapy as secondary prevention in the early phase of NVAF-related AIS have a better prognosis compared with patients who do not receive antithrombotic treatment. Recently, the RAF study showed that the best efficacy/safety profile was associated with anticoagulation started between 4 and 14 days from stroke onset. Based on the RAF study, the 2018 American Heart Association/American Stroke Association (AHA/ASA) guidelines suggest starting anticoagulants between 4 and 14 days from stroke onset with a class of recommendation IIa. Strong evidence for the use of direct oral anticoagulants (DOACs) in the early phase of NVAF-related AIS is lacking, because this kind of patients were excluded from phase III randomized clinical trials (RCT) and ad hoc RCTs are ongoing. However, the real life evidence suggests that early starting time of DOACs in patients with NVAF-related AIS is safe and associated with low recurrence risk and all-cause mortality. In the present review the Authors provide an update on anticoagulation in the early phase of NVAF-related AIS with focus on DOACs.

Abstract TP68: The Characteristics of Acute Ischemic Stroke Treatment Clinical Trials Over the Past Twenty Years: Implications for Future Trial Design

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Yi Dong ◽  
Pratik Y Chhatbar ◽  
Shimeng Liu ◽  
Qiang Dong ◽  
Bruce Ovbiagele ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Standard Care ◽  
Trial Design ◽  
Phase Iii ◽  
Care Group ◽  
Stroke Treatment ◽  
Mesh Terms

Introduction: There was a 20 years span between the landmark NINDS r-tPA trials and the recent spate of positive endovascular trials of acute ischemic stroke. The evolution of clinical trial design, characteristics of subjects, and nature of background standard care have not been properly studied. Such information could have consequences for future clinical trial designs. Objective: To systematically search the literature for randomized controlled trials of acute ischemic stroke and identify key patterns. Methods: We interrogated Pubmed from 1995 to 2015 with MeSH terms (Fig 1A). Inclusion criteria are: 1) acute intervention delivered within 24 hours of onset; 2) randomized trial with a control (either placebo or standard care) group with ≥20 subjects in each arm; 3) mRS used as an outcome at 3 months; 4) published in the English language. Data were extracted and effect sizes were calculated for both mortality and favorable outcome (mRS: 0-1). We also extracted data for baseline characteristics and analyzed trends over time. Results: Forty-six clinical trials were included with 19951 subjects and 38.5% of them were females. There were 8 phase II and 11 phase III trials, nine out of 46 are positive trials . Average number of subjects per trial was 443 and number of patient enrollments per year ranged from 23-270. Study-wise odd’s ratio ranged 0.15 - 3.97 for mortality and 0.30- 3.06 for favorable outcomes. Rate of mortality was 13.6% (0-44%) and favorable outcomes ranged 6-37% in control and 7.5-74.8% in intervention arm. Median onset of treatment ranged from 90 - 972 minutes. There are trends of increased NIHSS score at baseline for studies over the years. The type of intervention and baseline NIHSS are major determinants of mortality rate. Conclusions: Patterns existed in the acute ischemic stroke treatment trials. Understanding these patterns may inform the stroke community to better design trials in the future.

scholarly journals Neuroprotection for acute ischemic stroke: Who is most to blame for current failure ?

Stroke ◽  
2001 ◽  
Vol 32 (suppl_1) ◽  
pp. 372-372
Author(s):  
Antonio Davalos ◽  
Jose Castillo ◽  
Angel Chamorro
Keyword(s):  
Ischemic Stroke ◽  
High Risk ◽  
Acute Ischemic Stroke ◽  
Plasma Concentrations ◽  
Phase Iii ◽  
Neurologic Deterioration ◽  
Molecular Events ◽  
Phase Iii Trials ◽  
Early Worsening ◽  
Previous Phase

P179 Neuroprotection has so far proved disappointing in acute ischemic stroke. However, neither clinical nor biological cues of ongoing neurotoxicity were provided in previous phase III trials. Thus it remains unsettled whether faulty drug selection, inadequate patients′ traits, or both, explain treatment failure. In 258 patients with first ever acute hemispheric ischemic stroke we found that admission plasma concentrations of glutamate >200 μmol/L (OR, 26.1; 95%CI, 6.9 to 98.6), interleukin-6 >21.5 pg/mL (OR, 14.9; 95%CI, 4.4 to 50.8), and GABA <190 nmol/L (OR,5.5; 95%CI, 3.2 to 9.7), and NO-metabolites >5.0 μmol/mL in CSF (OR, 5.3; 95%CI, 1.5 to 18.5), were sensitive and specific independent predictors of patients at high-risk of early neurologic deterioration regardless of infarction topography, size, and mechanism. Sensitivity and specificity values are given in the table. Early neurologic deterioration is a harbinger of impending poor outcome that in many instances we could forecast using the aforementioned tests. As early neurologic deterioration most commonly reflects those molecular events that neuroprotectants are aimed to prevent, we advocate to include it as a primary end-point in forthcoming neuroprotectant trials. We also contend to launch large and expensive trials once smaller studies restricted to patients at high-risk of early worsening have disclosed laboratory indications of neuroprotection.

Sign in / Sign up

Export Citation Format

Share Document