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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
zhipeng xu, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01770197
First received: January 8, 2013
Last updated: April 1, 2013
Last verified: January 2013

January 8, 2013
April 1, 2013
January 2008
April 2013   (final data collection date for primary outcome measure)
National Institute of Health Stroke Scale score and modified Rankin Scale [ Time Frame: Outcome measure will be assessed at 24 weeks ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01770197 on ClinicalTrials.gov Archive Site
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Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window
The Feasibility and Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window in China

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.

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.

Observational [Patient Registry]
Observational Model: Case Control
Time Perspective: Prospective
24 Weeks
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Probability Sample

stroke patients in the 3-4.5 hour time window

Stroke
Drug: IV rt-PA
IV rt-PA treatment
Other Name: rt-PA
  • recombinant tissue plasminogen activator
    Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h.
    Intervention: Drug: IV rt-PA
  • 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.
    Intervention: Drug: IV rt-PA
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:stroke patients in the 3-4.5 hour time window -

Exclusion Criteria:stroke patients in more than 4.5 hour time window

-

Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01770197
20090101
Yes
zhipeng xu, Wuhan General Hospital of Guangzhou Military Command
Wuhan General Hospital of Guangzhou Military Command
Not Provided
Study Chair: Wuhan G H, High Wuhan General Hospital of Guangzhou Command
Wuhan General Hospital of Guangzhou Military Command
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP