ALteplase in Patients With LOW NIHSS and Specified Disabling Deficits
Status:
Recruiting
Trial end date:
2026-11-30
Target enrollment:
Participant gender:
Summary
About 1/3 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 58.9% and 68.7% (OR 1.48, 95%Cl 1.07-2.06), 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 78.2%
vs 81.5%), 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 4.5 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 CT/MRI screening in the Chinese population.
Phase:
Phase 4
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University