Clinical trial NCT01183533: Safety of Intravenous Thrombolysis for Wake-up Stroke
Official title: Safety of Intravenous Thrombolysis for Wake-up Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: Wake-Up Stroke
Ischemic stroke
ischemic stroke patients who wake-up with their symptoms
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well.
* 18 to 80 years old
* NIHSS (National Institutes of Health Stroke Scale) ≤25
* Blood Pressure ≤185 mmHg systolic \& ≤110 mmHg diastolic at the time of enrollment.

Treatment of higher systolic BP is permitted, prior to enrollment

* IV t-PA must be given within 3 hours of awakening from sleep
* Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment

Exclusion Criteria:

* CT Exclusion Criteria: Hypodensity \>1/3 middle cerebral artery (MCA) territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage
* Prior ischemic stroke within 3 months of the presenting event
* History of intracranial hemorrhage
* Known secured or unsecured cerebral aneurysm or vascular malformation
* Inability to control systolic BP \> 185 mmHg or diastolic BP \> 110 mmHg with IV anti-hypertensive medications
* Known coagulopathy or evidence of active bleeding
* Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event
* Gastrointestinal or genitourinary bleeding within 14 days of the event
* Treated with IV heparin within the previous 24 hours \& an abnormal (partial thromboplastin time) PTT
* Oral anticoagulants \& an (international normalized ratio) INR \>1.7
* Platelet count \<100,000
* Venous glucose either \<50 or \>450
* Any patient who qualifies for this protocol should not be treated with (intra-arterial therapy) IAT If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol

Primary outcomes:
measure: Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients
timeFrame: 24 hours
Secondary outcomes:
measure: 90-day Modified Rankin Scale (mRS) Score 0 or 1
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Houston
country: United States
facility: UT-Houston Health Science Center
state: Texas
Study officials:
affiliation: UT-Houston Health Science Center
name: Sean I Savitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Co-PI
name: Andrew D Barreto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barreto AD, Fanale CV, Alexandrov AV, Gaffney KC, Vahidy FS, Nguyen CB, Sarraj A, Rahbar M, Grotta JC, Savitz SI; Wake-Up Stroke Investigators. Prospective, open-label safety study of intravenous recombinant tissue plasminogen activator in wake-up stroke. Ann Neurol. 2016 Aug;80(2):211-8. doi: 10.1002/ana.24700. Epub 2016 Jul 12.