Trial Outcomes & Findings for Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B) (NCT NCT00252239)
NCT ID: NCT00252239
Last Updated: 2015-03-17
Results Overview
The scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score \>=4 are reported.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
3 months
Results posted on
2015-03-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
19
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
17
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)
Baseline characteristics by cohort
| Measure |
TNK 0.1 mg/kg
n=31 Participants
Lowest dose tenecteplase
|
TNK 0.25 mg/kg
n=31 Participants
Medium dose tenecteplase
|
TNK 0.4 mg/kg
n=19 Participants
Highest dose tenecteplase
|
tPA 0.9 mg/kg
n=31 Participants
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
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 19 • n=5 Participants
|
69 years
STANDARD_DEVIATION 15 • n=7 Participants
|
68 years
STANDARD_DEVIATION 16 • n=5 Participants
|
72 years
STANDARD_DEVIATION 16 • n=4 Participants
|
69 years
STANDARD_DEVIATION 17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
19 participants
n=5 Participants
|
31 participants
n=4 Participants
|
112 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe scale range is from 0 (perfect health without symptoms) to 6 (death). Percentage of participants with Modified Rankin Score \>=4 are reported.
Outcome measures
| Measure |
TNK 0.1 mg/kg
n=31 Participants
Lowest dose tenecteplase
|
TNK 0.25 mg/kg
n=31 Participants
Medium dose tenecteplase
|
TNK 0.4 mg/kg
n=19 Participants
Highest dose tenecteplase
|
tPA 0.9 mg/kg
n=30 Participants
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.
|
|---|---|---|---|---|
|
Functional Handicap (Modified Rankin Score)
|
22.6 percentage of participants
|
35.5 percentage of participants
|
31.6 percentage of participants
|
32.3 percentage of participants
|
Adverse Events
TNK 0.1 mg/kg
Serious events: 13 serious events
Other events: 25 other events
Deaths: 0 deaths
TNK 0.25 mg/kg
Serious events: 25 serious events
Other events: 24 other events
Deaths: 0 deaths
TNK 0.4 mg/kg
Serious events: 13 serious events
Other events: 17 other events
Deaths: 0 deaths
tPA 0.9 mg/kg
Serious events: 26 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TNK 0.1 mg/kg
n=31 participants at risk
Lowest dose tenecteplase
|
TNK 0.25 mg/kg
n=31 participants at risk
Medium dose tenecteplase
|
TNK 0.4 mg/kg
n=19 participants at risk
Highest dose tenecteplase
|
tPA 0.9 mg/kg
n=31 participants at risk
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.
|
|---|---|---|---|---|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/31 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
15.8%
3/19 • Number of events 3 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
General disorders
Hemorrhage/Bleeding - other
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
General disorders
Infection with unknown ANC
|
3.2%
1/31 • Number of events 1 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
15.8%
3/19 • Number of events 3 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
3.2%
1/31 • Number of events 1 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
6.5%
2/31 • Number of events 2 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Vascular disorders
Vascular - other
|
3.2%
1/31 • Number of events 1 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
|
Cardiac disorders
Cardiac General
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
General disorders
Death not associated with CTCAE term
|
0.00%
0/31 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/19 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Number of events 1 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Elevated creatinine
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Blood and lymphatic system disorders
Reduced hemoglobin
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
|
Infections and infestations
Infection with normal, Grade 1 or 2 neutrophils
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
|
Gastrointestinal disorders
Malignancy
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue - other
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Nervous system disorders
Neurology-other
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Metabolism and nutrition disorders
Sodium, serum high (hypernatremia
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Cardiac disorders
Valvular heart disease
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
0.00%
0/19 • 3 months
|
0.00%
0/31 • 3 months
|
|
Surgical and medical procedures
Vessel injury - artery
|
0.00%
0/31 • 3 months
|
0.00%
0/31 • 3 months
|
0.00%
0/19 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Nervous system disorders
CNS ischemia
|
16.1%
5/31 • Number of events 5 • 3 months
|
22.6%
7/31 • Number of events 7 • 3 months
|
26.3%
5/19 • Number of events 5 • 3 months
|
22.6%
7/31 • Number of events 7 • 3 months
|
Other adverse events
| Measure |
TNK 0.1 mg/kg
n=31 participants at risk
Lowest dose tenecteplase
|
TNK 0.25 mg/kg
n=31 participants at risk
Medium dose tenecteplase
|
TNK 0.4 mg/kg
n=19 participants at risk
Highest dose tenecteplase
|
tPA 0.9 mg/kg
n=31 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Pain
|
45.2%
14/31 • Number of events 14 • 3 months
|
25.8%
8/31 • Number of events 8 • 3 months
|
31.6%
6/19 • Number of events 6 • 3 months
|
12.9%
4/31 • Number of events 4 • 3 months
|
|
Blood and lymphatic system disorders
Blood/Bone marrow - other
|
16.1%
5/31 • Number of events 5 • 3 months
|
19.4%
6/31 • Number of events 6 • 3 months
|
26.3%
5/19 • Number of events 5 • 3 months
|
16.1%
5/31 • Number of events 5 • 3 months
|
|
Blood and lymphatic system disorders
Hemoglobin low
|
12.9%
4/31 • Number of events 4 • 3 months
|
29.0%
9/31 • Number of events 9 • 3 months
|
21.1%
4/19 • Number of events 4 • 3 months
|
12.9%
4/31 • Number of events 4 • 3 months
|
|
Metabolism and nutrition disorders
Potassium, serum low
|
16.1%
5/31 • Number of events 5 • 3 months
|
19.4%
6/31 • Number of events 6 • 3 months
|
21.1%
4/19 • Number of events 4 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
|
Skin and subcutaneous tissue disorders
Bruising in absence of grade 3 or 4 thrombocytopenia
|
6.5%
2/31 • Number of events 2 • 3 months
|
22.6%
7/31 • Number of events 7 • 3 months
|
10.5%
2/19 • Number of events 2 • 3 months
|
16.1%
5/31 • Number of events 5 • 3 months
|
|
Metabolism and nutrition disorders
Metabolic/laboratory - other
|
16.1%
5/31 • Number of events 5 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
15.8%
3/19 • Number of events 3 • 3 months
|
12.9%
4/31 • Number of events 4 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
9.7%
3/31 • Number of events 3 • 3 months
|
12.9%
4/31 • Number of events 4 • 3 months
|
15.8%
3/19 • Number of events 3 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high
|
6.5%
2/31 • Number of events 2 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
21.1%
4/19 • Number of events 4 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Number of events 2 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
15.8%
3/19 • Number of events 3 • 3 months
|
16.1%
5/31 • Number of events 5 • 3 months
|
|
General disorders
Nausea
|
9.7%
3/31 • Number of events 3 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
15.8%
3/19 • Number of events 3 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Metabolism and nutrition disorders
Calcium, serum low
|
6.5%
2/31 • Number of events 2 • 3 months
|
12.9%
4/31 • Number of events 4 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/31 • 3 months
|
12.9%
4/31 • Number of events 4 • 3 months
|
21.1%
4/19 • Number of events 4 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
2/31 • Number of events 2 • 3 months
|
12.9%
4/31 • Number of events 4 • 3 months
|
10.5%
2/19 • Number of events 2 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Psychiatric disorders
Mood alteration
|
3.2%
1/31 • Number of events 1 • 3 months
|
16.1%
5/31 • Number of events 5 • 3 months
|
10.5%
2/19 • Number of events 2 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Metabolism and nutrition disorders
Albumin, serum low
|
9.7%
3/31 • Number of events 3 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
|
Cardiac disorders
Valvular heart disease
|
6.5%
2/31 • Number of events 2 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
5.3%
1/19 • Number of events 1 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
|
Cardiac disorders
Cardiac general - other
|
6.5%
2/31 • Number of events 2 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
10.5%
2/19 • Number of events 2 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Renal and urinary disorders
Hemorrhage, GU
|
0.00%
0/31 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
21.1%
4/19 • Number of events 4 • 3 months
|
9.7%
3/31 • Number of events 3 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.2%
1/31 • Number of events 1 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
15.8%
3/19 • Number of events 3 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
General disorders
Fever, in the absence of neutropenia
|
3.2%
1/31 • Number of events 1 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
10.5%
2/19 • Number of events 2 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
3.2%
1/31 • Number of events 1 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
21.1%
4/19 • Number of events 4 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Magnesium, serum low
|
3.2%
1/31 • Number of events 1 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
10.5%
2/19 • Number of events 2 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes high
|
3.2%
1/31 • Number of events 1 • 3 months
|
6.5%
2/31 • Number of events 2 • 3 months
|
10.5%
2/19 • Number of events 2 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Pancreatic endocrine: glucose intolerance
|
6.5%
2/31 • Number of events 2 • 3 months
|
0.00%
0/31 • 3 months
|
15.8%
3/19 • Number of events 3 • 3 months
|
3.2%
1/31 • Number of events 1 • 3 months
|
Additional Information
Dr. E. Clarke Haley, Jr.
University of Virginia Health System
Phone: 434-924-8041
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place