Trial Outcomes & Findings for Safety of Intravenous Thrombolysis for Wake-up Stroke (NCT NCT01183533)
NCT ID: NCT01183533
Last Updated: 2014-11-25
Results Overview
The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Symptomatic was defined as significant clinical deterioration with at least a 4 point or more increase in the NIH Stroke scale.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
24 hours
Results posted on
2014-11-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Intravenous Thrombolysis for Wake-up Stroke
Baseline characteristics by cohort
| Measure |
Off Label Rt-PA
n=40 Participants
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.
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|---|---|
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Age, Continuous
|
60.8 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian, Non-Hispanic
|
17 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian, Hispanic
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
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40 participants
n=5 Participants
|
|
National Institutes of Health Stroke Scale score, median (range)
|
6.5 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Symptomatic was defined as significant clinical deterioration with at least a 4 point or more increase in the NIH Stroke scale.
Outcome measures
| Measure |
Off Label Rt-PA
n=40 Participants
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.
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|---|---|
|
Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients
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0 cases.
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SECONDARY outcome
Timeframe: 90 daysPopulation: \^ Note: 2 patients were not available for 90-day follow-up assessments.
Number of patients with mRS of 0 or 1 at 90 days. The mRS is a clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It has a minimum of 0 and a maximum of 6. Zero represents a patient that has no disability or residual stroke symptoms. A score of 1 is defined as: no significant disability: despite symptoms, able to carry out all usual duties and activities. The maximum score, 6, indicates death. A score of 2 is defined as slight disability: unable to perform all previous activities but able to look after own affairs without assistance; a score of 3 is defined as moderate disability: requiring some help but able to walk without assistance; a score of 4 is moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; a score of 5 is severe disability: bedridden, incontinent and requiring constant nursing care and attention.
Outcome measures
| Measure |
Off Label Rt-PA
n=38 Participants
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.
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|---|---|
|
90-day Modified Rankin Scale (mRS) Score 0 or 1
|
20 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Note: although 2 patients were not available for complete day 90 assessments, family/patient communication provided necessary mortality information.
Outcome measures
| Measure |
Off Label Rt-PA
n=40 Participants
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.
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|---|---|
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Mortality
|
2 participants
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Adverse Events
Off Label Rt-PA
Serious events: 6 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Off Label Rt-PA
n=40 participants at risk
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.
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|---|---|
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Nervous system disorders
New (recurrent) Ischemic Stroke
|
5.0%
2/40 • Number of events 2 • 30 days from rt-PA treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Infections and infestations
Abscess
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
General disorders
Death
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Nervous system disorders
Cerebral Edema, malignant
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Nervous system disorders
Seizures with neurological deterioration
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
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|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
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Other adverse events
| Measure |
Off Label Rt-PA
n=40 participants at risk
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.
|
|---|---|
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Nervous system disorders
Asymptomatic Intracranial Hemorrhage
|
15.0%
6/40 • Number of events 6 • 30 days from rt-PA treatment.
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|
Skin and subcutaneous tissue disorders
Orolingual Angioedema
|
5.0%
2/40 • Number of events 2 • 30 days from rt-PA treatment.
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Renal and urinary disorders
Urinary Tract Infection
|
7.5%
3/40 • Number of events 3 • 30 days from rt-PA treatment.
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|
Nervous system disorders
Encephalopathy
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5.0%
2/40 • Number of events 2 • 30 days from rt-PA treatment.
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|
Cardiac disorders
Atrial Fibrillation
|
10.0%
4/40 • Number of events 4 • 30 days from rt-PA treatment.
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|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.5%
3/40 • Number of events 3 • 30 days from rt-PA treatment.
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General disorders
Hypocalcemia
|
17.5%
7/40 • Number of events 7 • 30 days from rt-PA treatment.
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|
General disorders
Vertigo with nausea
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2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
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Respiratory, thoracic and mediastinal disorders
Shortness of breath (dyspnea)
|
7.5%
3/40 • Number of events 3 • 30 days from rt-PA treatment.
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|
Infections and infestations
Fever
|
7.5%
3/40 • Number of events 3 • 30 days from rt-PA treatment.
|
|
Blood and lymphatic system disorders
Hemorrhage (bleeding from ear)
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltrates (lower lobe)
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
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Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
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Respiratory, thoracic and mediastinal disorders
COPD (chronic obstructive pulmonary disease) Exacerbation
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Nervous system disorders
Neurological Worsening
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
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Renal and urinary disorders
Elevated Creatinine and/or BUN
|
7.5%
3/40 • Number of events 5 • 30 days from rt-PA treatment.
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|
Renal and urinary disorders
Hematuria
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
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Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
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Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
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|
Vascular disorders
Hypertension (uncontrolled)
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Vascular disorders
Deep Venous Thrombosis
|
5.0%
2/40 • Number of events 2 • 30 days from rt-PA treatment.
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|
Vascular disorders
Limb Ischemia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
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General disorders
Insomnia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
General disorders
Increased ESR rate (erythrocyte segmentation)
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
General disorders
Sore Throat
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
22.5%
9/40 • Number of events 9 • 30 days from rt-PA treatment.
|
|
Blood and lymphatic system disorders
Increased INR (international normalized ratio)
|
10.0%
4/40 • Number of events 4 • 30 days from rt-PA treatment.
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|
Blood and lymphatic system disorders
Neutrophilia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Blood and lymphatic system disorders
Monocytopenia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Blood and lymphatic system disorders
Monocytosis
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
Blood and lymphatic system disorders
Increased PTT (partial thromboplastin time)
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
General disorders
Hypoglycemia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
General disorders
Hyperglycemia
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32.5%
13/40 • Number of events 16 • 30 days from rt-PA treatment.
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General disorders
Hypokalemia
|
7.5%
3/40 • Number of events 3 • 30 days from rt-PA treatment.
|
|
General disorders
Hyperkalemia
|
7.5%
3/40 • Number of events 3 • 30 days from rt-PA treatment.
|
|
General disorders
Hypernatremia
|
7.5%
3/40 • Number of events 3 • 30 days from rt-PA treatment.
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|
General disorders
Hypomagnesemia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
General disorders
Hyponatremia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
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General disorders
Hypermagnesemia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
|
General disorders
Hypophosphatemia
|
2.5%
1/40 • Number of events 1 • 30 days from rt-PA treatment.
|
Additional Information
Sean I. Savitz, MD
University of Texas Health Science Center at Houston
Phone: 713-500-7083
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The study PI will submit the manuscript of any proposed publication to the sponsor at least 45 days before publication, and the sponsor shall have the right to review and comment upon the publication. The sponsor shall provide any comments to investigator within 30 days of receipt of the proposed publication or presentation. At the end of the 30 day period, the PI shall be free to proceed with the publication or presentation provided he or she has complied with the sponsor's feedback.
- Publication restrictions are in place
Restriction type: OTHER