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Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)

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ClinicalTrials.gov Identifier: NCT00252239
Recruitment Status : Terminated (Slow enrollment)
First Posted : November 11, 2005
Results First Posted : January 19, 2015
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
E. Clarke Haley, University of Virginia

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Drug: tenecteplase
Drug: tissue plasminogen activator, tPA

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TNK 0.1 mg/kg Lowest dose tenecteplase
TNK 0.25 mg/kg Medium dose tenecteplase
TNK 0.4 mg/kg Highest dose tenecteplase
tPA 0.9 mg/kg

tissue plasminogen activator, tPA

tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.


Participant Flow:   Overall Study
    TNK 0.1 mg/kg   TNK 0.25 mg/kg   TNK 0.4 mg/kg   tPA 0.9 mg/kg
STARTED   31   31   19   31 
COMPLETED   30   31   17   30 
NOT COMPLETED   1   0   2   1 
Withdrawal by Subject                1                0                0                1 
Lost to Follow-up                0                0                2                0 



  Baseline Characteristics

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
TNK 0.1 mg/kg Lowest dose tenecteplase
TNK 0.25 mg/kg Medium dose tenecteplase
TNK 0.4 mg/kg Highest dose tenecteplase
tPA 0.9 mg/kg

tissue plasminogen activator, tPA

tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.

Total Total of all reporting groups

Baseline Measures
   TNK 0.1 mg/kg   TNK 0.25 mg/kg   TNK 0.4 mg/kg   tPA 0.9 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   31   19   31   112 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (19)   69  (15)   68  (16)   72  (16)   69  (17) 
Gender 
[Units: Participants]
         
Female   19   15   6   14   54 
Male   12   16   13   17   58 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   1   2   0   3 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   5   4   4   5   18 
White   24   26   12   25   87 
More than one race   0   0   0   0   0 
Unknown or Not Reported   2   0   1   1   4 
Region of Enrollment 
[Units: Participants]
         
United States   31   31   19   31   112 


  Outcome Measures

1.  Primary:   Functional Handicap (Modified Rankin Score)   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Premature termination limits any conclusions from the trial.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. E. Clarke Haley, Jr.
Organization: University of Virginia Health System
phone: 434-924-8041
e-mail: ech@virginia.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: E. Clarke Haley, University of Virginia
ClinicalTrials.gov Identifier: NCT00252239     History of Changes
Other Study ID Numbers: 11231
R01NS045170 ( U.S. NIH Grant/Contract )
R01NS037666 ( U.S. NIH Grant/Contract )
First Submitted: November 10, 2005
First Posted: November 11, 2005
Results First Submitted: January 12, 2015
Results First Posted: January 19, 2015
Last Update Posted: March 17, 2015