acute ischemic stroke
Conditions
Interventions
Long-course group: sequential therapy with rhTNK-tPA thrombolysis combined with butylphthalide (21–90 days):None
Short-course group: sequential therapy with butylphthalide following rhTNK-tPA thrombolysis (14–21 days):None
Sponsors
Shanghai Tongren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Acute ischemic stroke diagnosed with definite evidence, onset within 24 hours, accompanied by neurological deficits; 3. First-ever stroke, or ischemic stroke with a history of previous cerebral infarction but modified Rankin Scale (mRS) score <= 1 and onset within 24 hours; 4. Cerebral hemorrhage excluded by computed tomography (CT); 5. Planned for intravenous thrombolysis; 6. The subject or legal representative voluntarily consents to participate in the clinical study and signs written informed consent; 7. Consecutive enrollment and observation for eligible patients.
Exclusion criteria
Exclusion criteria: 1.Intracranial hemorrhagic diseases shown on cranial CT; 2.Diseases with bleeding diathesis; 3.Severe hepatic and renal dysfunction; 4.Patients complicated with malignant tumors or undergoing anti-tumor therapy; 5.Atopic constitution, or history of allergy to celery or butylphthalide; 6.Cardiac insufficiency or multiple system failure; 7.Pregnant or lactating women; 8.Patients with dementia or psychiatric disorders who cannot comply with follow-up; 9.Other patients considered ineligible for the study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with favorable functional outcome (mRS score 0–2) at 90 days after receiving sequential therapy of rhTNK-tPA combined with butylphthalide of different durations, with a focu; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with recurrent symptomatic ischemic stroke at 90 days after treatment;;proportion of patients with vascular recanalization at 24 hours after treatment;Proportion of symptomatic hemorrhagic transformation;90-day mortality - Proportion of symptomatic hemorrhagic transformation;Proportion of patients with favorable functional outcome (mRS score 0–1) at 90 days after treatment;;Proportion of patients with symptomatic cerebral edema and intracranial hemorrhage at 24 hours after treatment;;Proportion of combined vascular events (new-onset atrial fibrillation, recurrent symptomatic stroke, myocardial infarction, vascular death) at 90 days after treatment.; | — |
Countries
China
Contacts
Public ContactXueyuan Liu
Shanghai Tongren Hospital
Outcome results
None listed