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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01770197
• Other study ID #: 20090101
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 8, 2013
• Last updated: December 9, 2014
• Start date: January 2008
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Wuhan General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• IV rt-PA
IV rt-PA treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan General Hospital of Guangzhou Military Command

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

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