Safety of Intravenous Thrombolysis for Wake-up Stroke

Ischemic Stroke Clinical Trial

— Wake-Up Stroke  

Official title:

Safety of Intravenous Thrombolysis for Wake-up Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183533
• Other study ID #: HSC-MS-10-0195
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2010
• Last updated: November 24, 2014
• Start date: July 2010
• Est. completion date: January 2014

Study information

• Verified date: November 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	Swedish Medical Center	Englewood	Colorado
United States	UT-Houston Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours	Yes
Secondary	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.	90 days	No
Secondary	Mortality		90 days	Yes