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

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ClinicalTrials.gov Identifier: NCT01770197
Recruitment Status : Unknown
Verified December 2014 by zhipeng xu, Wuhan General Hospital of Guangzhou Military Command.
Recruitment status was:  Enrolling by invitation
First Posted : January 17, 2013
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
zhipeng xu, 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.

Condition or disease Intervention/treatment
Stroke Drug: IV 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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
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
Study Start Date : January 2008
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase
U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. National Institute of Health Stroke Scale score and modified Rankin Scale [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770197


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

Additional Information:
Responsible Party: zhipeng xu, Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01770197     History of Changes
Other Study ID Numbers: 20090101
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action