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

• Conditions: Stroke
• Interventions: Drug: IV rt-PA

• Registration Number: NCT01770197
• Lead Sponsor: Wuhan General Hospital of Guangzhou Military Command

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-17
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

stroke patients in the 3-4.5 hour time window -

Exclusion Criteria

stroke patients in more than 4.5 hour time window

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
recombinant tissue plasminogen activator	IV rt-PA	Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h.
rt-PA	IV rt-PA	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.

Primary Outcome Measures

Name	Time	Method
National Institute of Health Stroke Scale score and modified Rankin Scale	Outcome measure will be assessed at 24 weeks	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