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
  Purpose

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.


Condition Intervention
Stroke
Drug: IV rt-PA

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 24 Weeks
Official Title: The Feasibility and Outcome of Intravenous Thrombolysis for Stroke Patients in the 3-4.5 Hour Time Window in China

Resource links provided by NLM:


Further study details as provided by Wuhan General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
recombinant tissue plasminogen activator
Stroke patients with rt-PA treatment in the 3-4.5 hour time window were compared with those within 3h.
Drug: IV rt-PA
IV rt-PA treatment
Other Name: 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.
Drug: IV rt-PA
IV rt-PA treatment
Other Name: rt-PA

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

stroke patients in the 3-4.5 hour time window

Criteria

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

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

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01770197

Sponsors and Collaborators
Wuhan General Hospital of Guangzhou Military Command
Investigators
Study Chair: Wuhan G H, High Wuhan General Hospital of Guangzhou Command
  More Information

Additional Information:
No publications provided

Responsible Party: zhipeng xu, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01770197     History of Changes
Other Study ID Numbers: 20090101
Study First Received: January 8, 2013
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wuhan General Hospital of Guangzhou Military Command:
China
Stroke
Thrombolytic therapy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 28, 2014