Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window

Study Overview
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Brief Summary
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The time window for intravenous recombinant tissue plasminogen activator treatment in ischemic stroke patients has been extended to 4.5h. Little is known about intravenous recombinant tissue plasminogen activator use in the 3-4.5 hour time window among Chinese stroke patients. This exploratory study was to describe the feasibility and outcome of treatment with intravenous recombinant tissue plasminogen activator in the expanded time window, and to offer suggestions for future clinical work in China.

Detailed Description
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Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up. The safety of intravenous recombinant tissue plasminogen activator was assessed by the rate of mortality, intracerebral hemorrhage and other common complications. Multivariate logistic regression models were used to evaluate factors associated with favorable clinical outcome.

Official Title
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The Feasibility and Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window in China

Conditions
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Stroke

Intervention / Treatment
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* Drug: IV rt-PA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:stroke patients in the 3-4.5 hour time window - Exclusion Criteria:stroke patients in more than 4.5 hour time window -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| recombinant tissue plasminogen activator<br>Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h. | Drug: IV rt-PA<br>* IV rt-PA treatment<br>* Other names: rt-PA;|
| rt-PA<br>One group of was treated with standard recombinant tissue plasminogen activator therapy in 3h and the other group of stroke patients was treated within 3-4.5h. | Drug: IV rt-PA<br>* IV rt-PA treatment<br>* Other names: rt-PA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Health Stroke Scale score and modified Rankin Scale | Favorable clinical outcome of intravenous recombinant tissue plasminogen activator was assessed by absolute changes in the National Institute of Health Stroke Scale score at 24 hours and by the improvement of modified Rankin Scale score at discharge or 6-month follow-up | Outcome measure will be assessed at 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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China, Stroke, Thrombolytic therapy