Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06115070
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-10-19
Brief Title:
ALteplase in Patients With LOW NIHSS and Specified Disabling Deficits
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
ALteplase for the Treatment of Acute Ischemic Stroke in Patients With LOW National Institutes of Health Stroke Scale and Specified Disabling Deficits
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLOW
Brief Summary:
About 13 patients with mild stroke have poor prognosis whether patients with this type undergo thrombolysis has been a controversial issue A pooled analysis published in the Lancet in 2014 included 9 high-quality RCT studies of intravenous thrombolysis such as NINDS and IST3 and a total of 666 10 patients with mild stroke were included in the analysis For mild stroke the proportion of good prognosis in the control group and the alteplase group was 589 and 687 OR 148 95Cl 107-206 respectively Therefore guidelines recommended alteplase thrombolytic therapy for patients with mild stroke However PRISMS a randomized controlled trial of intravenous thrombolytic therapy for mild stroke published in 2018 found that alteplase intravenous thrombolytic therapy did not improve clinical outcomes compared with aspirin in patients with mild non-disabled stroke 90-day mRS 0-1 ratio 782 vs 815 and the incidence of symptomatic intracranial hemorrhage was higher However a major limitation of the PRISMS study was that more than 85 of patients had numbness and dysarticulation so this conclusion cannot be extrapolated to patients with other mild stroke symptoms Moreover due to the early termination of the sponsorship of this trial the number of enrolled cases did not reach the pre-designed number resulting in a serious decline in the authenticity of the study results
Symptoms and outcomes of minor stroke are important criteria for assessment However there is currently no uniform standard for the assessment of disability Therefore the center developed a mild stroke EMSS assessment scale to refine the disability assessment of stroke symptoms It was found that intravenous thrombolytic therapy was safe and effective for patients with symptoms such as dizziness disorientation memory impairment decreased muscle strength at the proximal end of one limb and ataxia while standing
Therefore the purpose of this study was to investigate whether ischemic stroke patients with onset or detection time within 45 hours and mild stroke patients with NIHSS score 5 with any of the following symptoms dizziness disorientation memory impairment single proximal muscle strength decline or ataxia while standing could benefit from intravenous thrombolysis based on CTMRI screening in the Chinese population
Symptoms and outcomes of minor stroke are important criteria for assessment However there is currently no uniform standard for the assessment of disability Therefore the center developed a mild stroke EMSS assessment scale to refine the disability assessment of stroke symptoms It was found that intravenous thrombolytic therapy was safe and effective for patients with symptoms such as dizziness disorientation memory impairment decreased muscle strength at the proximal end of one limb and ataxia while standing
Therefore the purpose of this study was to investigate whether ischemic stroke patients with onset or detection time within 45 hours and mild stroke patients with NIHSS score 5 with any of the following symptoms dizziness disorientation memory impairment single proximal muscle strength decline or ataxia while standing could benefit from intravenous thrombolysis based on CTMRI screening in the Chinese population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None