https://ogma.newcastle.edu.au/vital/access/ /manager/Index ${session.getAttribute("locale")} 5 Low-versus standard-dose alteplase in patients on prior antiplatelet therapy: the ENCHANTED Trial (Enhanced Control of Hypertension and Thrombolysis Stroke Study) https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:34282 Tue 26 Feb 2019 12:16:34 AEDT ]]> Safety and efficacy of sonothrombolysis for acute ischaemic stroke: a multicentre, double-blind, phase 3, randomised controlled trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:41919 Tue 16 Aug 2022 11:00:51 AEST ]]> Low-dose vs standard-dose alteplase for patients with acute ischemic stroke: secondary analysis of the ENCHANTED randomized clinical trial https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:32180 .37 for interaction). Similarly, the treatment effects of low- vs standard-dose alteplase on function outcome (ordinal shift of the modified Rankin Scale) in Asians (odds ratio, 1.05; 95% CI, 0.90-1.22) was consistent with non-Asians (odds ratio, 0.93; 95% CI, 0.76-1.14) (P = .32 for interaction). There were generally consistent reductions in rates of symptomatic intracerebral hemorrhage with low-dose alteplase, although this reduction was not statistically significant by age, ethnicity, or severity. Conclusions and Relevance: This analysis found that the effects of low-dose alteplase were not clearly superior to the effects of standard-dose alteplase on death or disability in key demographic subgroups of patients with AIS. Further investigation is required to identify patients with AIS who may benefit from low-dose alteplase. Trial Resgistration: clinicaltrials.gov Identifier: NCT01422616.]]> Thu 27 Jan 2022 15:56:56 AEDT ]]> Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:36545 post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p < 0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06–0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89–1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0–2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01–2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies.]]> Thu 09 Dec 2021 11:02:10 AEDT ]]> Blood pressure excursions in acute ischemic stroke patients treated with intravenous thrombolysis https://ogma.newcastle.edu.au/vital/access/ /manager/Repository/uon:46103 185/105 mmHg) during the first 24 h following tPA-bolus. The majority of BP excursions (46%) occurred within the first 75 min from tPA-bolus. Patients with at least one BP excursion in the first 24 h following tPA bolus had significantly lower rates of independent functional outcome at 90 days (31 vs. 40.1%, P = 0.028). The total number of BP excursions was associated with decreased odds of 24-h clinical recovery (OR = 0.88, 95% CI:0.80–0.96), 24-h neurological improvement (OR = 0.87, 95% CI: 0.81–0.94), 7-day functional improvement (common OR = 0.92, 95% CI: 0.87–0.97), 90-day functional improvement (common OR = 0.94, 95% CI: 0.88–0.98) and 90-day independent functional outcome (OR = 0.90, 95% CI: 0.82–0.98) in analyses adjusted for potential confounders. DBP excursions were independently associated with increased odds of any intracranial hemorrhage (OR = 1.26, 95% CI: 1.04–1.53). Conclusion: BP excursions above guideline thresholds during the first 24 h following tPA administration for AIS are common and are independently associated with adverse clinical outcomes.]]> Fri 11 Nov 2022 15:33:52 AEDT ]]>