A Phase 2 interventional study of Alteplase (iv t-PA) in Ischemic Stroke, sponsored by The University of Texas Health Science Center, Houston. Completed at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-11-25.
Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment
The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV t-PA) in ischemic stroke patients who present to the emergency department (ED) after awakening with the symptoms of suspected ischemic stroke.
This is an open label, multi-center, safety study of acute treatment with IV alteplase in ischemic stroke patients who wake-up with their symptoms. The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Clinical improvement defined as a decrease in the National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, 3 days and 90 days and modified Rankin Scale (mRS) score at 3 and 90 days. For patients that have computed tomographic angiogram (CTA) and computed tomographic perfusion (CTP), the incidence of large vessel occlusion will be quantified.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Treatment of higher systolic BP is permitted, prior to enrollment
Exclusion Criteria:
off label rt-PA used on all subject enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
Drug: 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.
Also known as: Activase®, Alteplase, tissue plasminogen activator, t-PA
Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients
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.
Time frame: 24 hours
90-day Modified Rankin Scale (mRS) Score 0 or 1
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.
Time frame: 90 days
Mortality
Time frame: 90 days
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.
| Milestone | Off Label Rt-PA |
|---|---|
| Started | 40 |
| Completed | 40 |
| Not completed | 0 |
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.
| cases. | Off Label Rt-PA |
|---|---|
| Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients | 0 |
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.
| participants | Off Label Rt-PA |
|---|---|
| 90-day Modified Rankin Scale (mRS) Score 0 or 1 | 20 |
| participants | Off Label Rt-PA |
|---|---|
| Mortality | 2 |
Collected over 30 days from rt-PA treatment.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Off Label Rt-PA | — | 6/40 (15%) | 30/40 (75%) |
| Event | Off Label Rt-PA |
|---|---|
| New (recurrent) Ischemic StrokeNervous system disorders | 2/40 |
| DeathRespiratory, thoracic and mediastinal disorders | 1/40 |
| AbscessInfections and infestations | 1/40 |
| DeathGeneral disorders | 1/40 |
| Cerebral Edema, malignantNervous system disorders | 1/40 |
| Seizures with neurological deteriorationNervous system disorders | 1/40 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/40 |
| Event | Off Label Rt-PA |
|---|---|
| HyperglycemiaGeneral disorders | 13/40 |
| AnemiaBlood and lymphatic system disorders | 9/40 |
| HypocalcemiaGeneral disorders | 7/40 |
| Asymptomatic Intracranial HemorrhageNervous system disorders | 6/40 |
| Atrial FibrillationCardiac disorders | 4/40 |
| Increased INR (international normalized ratio)Blood and lymphatic system disorders | 4/40 |
| Urinary Tract InfectionRenal and urinary disorders | 3/40 |
| Musculoskeletal PainMusculoskeletal and connective tissue disorders | 3/40 |
| Shortness of breath (dyspnea)Respiratory, thoracic and mediastinal disorders | 3/40 |
| FeverInfections and infestations | 3/40 |
| Age, Continuous(years) | Off Label Rt-PA |
|---|---|
| Mean | 60.8 ± 13.2 |
| Sex: Female, Male(Participants) | Off Label Rt-PA |
|---|---|
| Female | 20 |
| Male | 20 |
| Race/Ethnicity, Customized(participants) | Off Label Rt-PA |
|---|---|
| Caucasian, Non-Hispanic | 17 |
| Caucasian, Hispanic | 6 |
| African American | 16 |
| Asian | 1 |
| Region of Enrollment(participants) | Off Label Rt-PA |
|---|---|
| United States | 40 |
| National Institutes of Health Stroke Scale score, median (range)(units on a scale) | Off Label Rt-PA |
|---|---|
| Median | 6.5 (2 to 24) |
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The University of Texas Health Science Center, Houston