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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
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TNK 0.1 mg/kg TNK 0.25 mg/kg TNK 0.4 mg/kg tPA 0.9 mg/kg
Hide Arm/Group Description Lowest dose tenecteplase Medium dose tenecteplase Highest dose tenecteplase

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.

Period Title: Overall Study
Started 31 31 19 31
Completed 30 31 17 30
Not Completed 1 0 2 1
Reason Not Completed
Withdrawal by Subject             1             0             0             1
Lost to Follow-up             0             0             2             0
Arm/Group Title TNK 0.1 mg/kg TNK 0.25 mg/kg TNK 0.4 mg/kg tPA 0.9 mg/kg Total
Hide Arm/Group Description Lowest dose tenecteplase Medium dose tenecteplase Highest dose tenecteplase

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 of all reporting groups
Overall Number of Baseline Participants 31 31 19 31 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 19 participants 31 participants 112 participants
67  (19) 69  (15) 68  (16) 72  (16) 69  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 19 participants 31 participants 112 participants
Female
19
  61.3%
15
  48.4%
6
  31.6%
14
  45.2%
54
  48.2%
Male
12
  38.7%
16
  51.6%
13
  68.4%
17
  54.8%
58
  51.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 19 participants 31 participants 112 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.2%
2
  10.5%
0
   0.0%
3
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  16.1%
4
  12.9%
4
  21.1%
5
  16.1%
18
  16.1%
White
24
  77.4%
26
  83.9%
12
  63.2%
25
  80.6%
87
  77.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   6.5%
0
   0.0%
1
   5.3%
1
   3.2%
4
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 31 participants 19 participants 31 participants 112 participants
31 31 19 31 112
1.Primary Outcome
Title Functional Handicap (Modified Rankin Score)
Hide Description The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score >=4 are reported.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TNK 0.1 mg/kg TNK 0.25 mg/kg TNK 0.4 mg/kg tPA 0.9 mg/kg
Hide Arm/Group Description:
Lowest dose tenecteplase
Medium dose tenecteplase
Highest dose tenecteplase

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.

Overall Number of Participants Analyzed 31 31 19 30
Measure Type: Number
Unit of Measure: percentage of participants
22.6 35.5 31.6 32.3
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TNK 0.1 mg/kg TNK 0.25 mg/kg TNK 0.4 mg/kg tPA 0.9 mg/kg
Hide Arm/Group Description Lowest dose tenecteplase Medium dose tenecteplase Highest dose tenecteplase

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.

All-Cause Mortality
TNK 0.1 mg/kg TNK 0.25 mg/kg TNK 0.4 mg/kg tPA 0.9 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
TNK 0.1 mg/kg TNK 0.25 mg/kg TNK 0.4 mg/kg tPA 0.9 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/31 (41.94%)      25/31 (80.65%)      13/19 (68.42%)      26/31 (83.87%)    
Blood and lymphatic system disorders         
Reduced hemoglobin  1  1/31 (3.23%)  1 0/31 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0
Cardiac disorders         
Cardiac ischemia/infarction  1  1/31 (3.23%)  1 2/31 (6.45%)  2 1/19 (5.26%)  1 1/31 (3.23%)  1
Supraventricular and nodal arrhythmia  1  2/31 (6.45%)  2 0/31 (0.00%)  0 0/19 (0.00%)  0 2/31 (6.45%)  2
Cardiac General  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 2/31 (6.45%)  2
Left ventricular systolic dysfunction  1  0/31 (0.00%)  0 0/31 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0
Valvular heart disease  1  0/31 (0.00%)  0 1/31 (3.23%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0
Ventricular arrhythmia  1  0/31 (0.00%)  0 1/31 (3.23%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0
Gastrointestinal disorders         
Dysphagia  1  0/31 (0.00%)  0 1/31 (3.23%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0
Malignancy  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1
General disorders         
Hemorrhage/Bleeding - other  1 [1]  0/31 (0.00%)  0 1/31 (3.23%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0
Infection with unknown ANC  1  1/31 (3.23%)  1 1/31 (3.23%)  1 3/19 (15.79%)  3 1/31 (3.23%)  1
Death not associated with CTCAE term  1  0/31 (0.00%)  0 2/31 (6.45%)  2 0/19 (0.00%)  0 0/31 (0.00%)  0
Infections and infestations         
Infection with Grade 3 or 4 neutrophils  1  0/31 (0.00%)  0 0/31 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0
Infection with normal, Grade 1 or 2 neutrophils  1  0/31 (0.00%)  0 0/31 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0
Metabolism and nutrition disorders         
Sodium, serum high (hypernatremia  1  0/31 (0.00%)  0 0/31 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Fracture  1  0/31 (0.00%)  0 1/31 (3.23%)  1 0/19 (0.00%)  0 1/31 (3.23%)  1
Musculoskeletal/soft tissue - other  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1
Nervous system disorders         
Hemorrhage, CNS  1 [2]  0/31 (0.00%)  0 2/31 (6.45%)  2 3/19 (15.79%)  3 1/31 (3.23%)  1
Somnolence/depressed level of consciousness  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 2/31 (6.45%)  2
Neurology-other  1  0/31 (0.00%)  0 1/31 (3.23%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0
Seizure  1  0/31 (0.00%)  0 1/31 (3.23%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0
CNS ischemia  1  5/31 (16.13%)  5 7/31 (22.58%)  7 5/19 (26.32%)  5 7/31 (22.58%)  7
Renal and urinary disorders         
Renal failure  1  0/31 (0.00%)  0 1/31 (3.23%)  1 1/19 (5.26%)  1 2/31 (6.45%)  2
Elevated creatinine  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1
Urinary frequency/urgency  1  1/31 (3.23%)  1 0/31 (0.00%)  0 0/19 (0.00%)  0 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Hypoxia  1  0/31 (0.00%)  0 0/31 (0.00%)  0 1/19 (5.26%)  1 1/31 (3.23%)  1
Adult Respiratory Distress Syndrome  1  0/31 (0.00%)  0 0/31 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0
Aspiration  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1
Pleural effusion (non-malignant)  1  0/31 (0.00%)  0 0/31 (0.00%)  0 1/19 (5.26%)  1 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders         
Ulceration  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1
Surgical and medical procedures         
Vessel injury - artery  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1
Vascular disorders         
Vascular - other  1  1/31 (3.23%)  1 2/31 (6.45%)  2 1/19 (5.26%)  1 0/31 (0.00%)  0
Hypotension  1  1/31 (3.23%)  1 1/31 (3.23%)  1 0/19 (0.00%)  0 0/31 (0.00%)  0
Thrombosis/thrombus/embolism  1  0/31 (0.00%)  0 0/31 (0.00%)  0 0/19 (0.00%)  0 1/31 (3.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Retroperitoneal hemorrhage
[2]
Symptomatic hemorrhage defined as clinically important neurological worsening lasting more than 8 hours and judged by independent adjucator to have been caused by blood seen on head CT scanning
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TNK 0.1 mg/kg TNK 0.25 mg/kg TNK 0.4 mg/kg tPA 0.9 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/31 (80.65%)      24/31 (77.42%)      17/19 (89.47%)      20/31 (64.52%)    
Blood and lymphatic system disorders         
Blood/Bone marrow - other  1  5/31 (16.13%)  5 6/31 (19.35%)  6 5/19 (26.32%)  5 5/31 (16.13%)  5
Hemoglobin low  1  4/31 (12.90%)  4 9/31 (29.03%)  9 4/19 (21.05%)  4 4/31 (12.90%)  4
Lymphopenia  1  2/31 (6.45%)  2 4/31 (12.90%)  4 2/19 (10.53%)  2 2/31 (6.45%)  2
Neutrophils/granulocytes high  1  1/31 (3.23%)  1 2/31 (6.45%)  2 2/19 (10.53%)  2 1/31 (3.23%)  1
Cardiac disorders         
Valvular heart disease  1  2/31 (6.45%)  2 3/31 (9.68%)  3 1/19 (5.26%)  1 3/31 (9.68%)  3
Cardiac general - other  1  2/31 (6.45%)  2 2/31 (6.45%)  2 2/19 (10.53%)  2 2/31 (6.45%)  2
Gastrointestinal disorders         
Constipation  1  3/31 (9.68%)  3 4/31 (12.90%)  4 3/19 (15.79%)  3 1/31 (3.23%)  1
Hemorrhage, GI  1  1/31 (3.23%)  1 1/31 (3.23%)  1 4/19 (21.05%)  4 1/31 (3.23%)  1
General disorders         
Pain  1  14/31 (45.16%)  14 8/31 (25.81%)  8 6/19 (31.58%)  6 4/31 (12.90%)  4
Nausea  1  3/31 (9.68%)  3 3/31 (9.68%)  3 3/19 (15.79%)  3 2/31 (6.45%)  2
Fever, in the absence of neutropenia  1  1/31 (3.23%)  1 2/31 (6.45%)  2 2/19 (10.53%)  2 2/31 (6.45%)  2
Metabolism and nutrition disorders         
Potassium, serum low  1  5/31 (16.13%)  5 6/31 (19.35%)  6 4/19 (21.05%)  4 3/31 (9.68%)  3
Metabolic/laboratory - other  1  5/31 (16.13%)  5 3/31 (9.68%)  3 3/19 (15.79%)  3 4/31 (12.90%)  4
Glucose, serum-high  1  2/31 (6.45%)  2 3/31 (9.68%)  3 4/19 (21.05%)  4 2/31 (6.45%)  2
Calcium, serum low  1  2/31 (6.45%)  2 4/31 (12.90%)  4 1/19 (5.26%)  1 3/31 (9.68%)  3
Albumin, serum low  1  3/31 (9.68%)  3 2/31 (6.45%)  2 1/19 (5.26%)  1 3/31 (9.68%)  3
Magnesium, serum low  1  1/31 (3.23%)  1 2/31 (6.45%)  2 2/19 (10.53%)  2 1/31 (3.23%)  1
Pancreatic endocrine: glucose intolerance  1  2/31 (6.45%)  2 0/31 (0.00%)  0 3/19 (15.79%)  3 1/31 (3.23%)  1
Nervous system disorders         
Hemorrhage, CNS  1 [1]  0/31 (0.00%)  0 4/31 (12.90%)  4 4/19 (21.05%)  4 2/31 (6.45%)  2
Psychiatric disorders         
Mood alteration  1  1/31 (3.23%)  1 5/31 (16.13%)  5 2/19 (10.53%)  2 2/31 (6.45%)  2
Renal and urinary disorders         
Hemorrhage, GU  1  0/31 (0.00%)  0 1/31 (3.23%)  1 4/19 (21.05%)  4 3/31 (9.68%)  3
Respiratory, thoracic and mediastinal disorders         
Atelectasis  1  1/31 (3.23%)  1 2/31 (6.45%)  2 3/19 (15.79%)  3 1/31 (3.23%)  1
Skin and subcutaneous tissue disorders         
Bruising in absence of grade 3 or 4 thrombocytopenia  1  2/31 (6.45%)  2 7/31 (22.58%)  7 2/19 (10.53%)  2 5/31 (16.13%)  5
Vascular disorders         
Hypertension  1  2/31 (6.45%)  2 1/31 (3.23%)  1 3/19 (15.79%)  3 5/31 (16.13%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Asymptomatic blood on head CT scan not accompanied by neurological worsening
Premature termination limits any conclusions from the trial.
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
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