Safety of Intravenous Thrombolysis for Wake-up Stroke (Wake-Up Stroke)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Sean Savitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01183533
First received: August 16, 2010
Last updated: November 24, 2014
Last verified: November 2014
Results First Received: October 28, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ischemic Stroke
Intervention: Drug: Alteplase (iv t-PA)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was open for enrollment (began recruiting and screening for eligible patients) on July 13, 2010. The date of first enrollment was October 5, 2010 and the date of last enrollment was October 5, 2013. All patients were enrolled at one of five participating centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable.

Reporting Groups
  Description
Off Label Rt-PA

Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.

Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.


Participant Flow:   Overall Study
    Off Label Rt-PA  
STARTED     40 [1]
COMPLETED     40 [2]
NOT COMPLETED     0  
[1] Between Oct 2010 and Oct 2013.
[2] - all pre-planned 40 patients received the study medication.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Off Label Rt-PA

Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.

Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.


Baseline Measures
    Off Label Rt-PA  
Number of Participants  
[units: participants]
  40  
Age  
[units: years]
Mean ± Standard Deviation
  60.8  ± 13.2  
Gender  
[units: participants]
 
Female     20  
Male     20  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian, Non-Hispanic     17  
Caucasian, Hispanic     6  
African American     16  
Asian     1  
Region of Enrollment  
[units: participants]
 
United States     40  
National Institutes of Health Stroke Scale score, median (range) [1]
[units: units on a scale]
Median ( Full Range )
  6.5  
  ( 2 to 24 )  
[1] National Institutes of Health Stroke Scale (NIHSS) score is a numerical 0-42 point scale that defines the severity of stroke deficits. It is routinely used in both the clinical assessment of patients as well as a research tool. Zero indicates a normal exam with no stroke deficits; whereas 42 indicates a severely affected individual who is comatose and unable to move their extremities. Unit of measure: "units on a scale".



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients   [ Time Frame: 24 hours ]

2.  Secondary:   90-day Modified Rankin Scale (mRS) Score 0 or 1   [ Time Frame: 90 days ]

3.  Secondary:   Mortality   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The single-arm / open-label design suffers from limitations such as possible bias in patient selection and outcome assessment. However, adverse events were adjudicated by the DSMB. Small trial size warrants caution; further studies are necessary.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sean I. Savitz, MD
Organization: University of Texas Health Science Center at Houston
phone: 713-500-7083
e-mail: sean.i.savitz@uth.tmc.edu


No publications provided


Responsible Party: Sean Savitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01183533     History of Changes
Other Study ID Numbers: HSC-MS-10-0195
Study First Received: August 16, 2010
Results First Received: October 28, 2014
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration