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Safety of Intravenous Thrombolysis for Wake-up Stroke (Wake-Up Stroke)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Sean Savitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01183533
First received: August 16, 2010
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Drug: Alteplase (iv t-PA)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Intravenous Thrombolysis for Wake-up Stroke

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Frequency of Symptomatic Hemorrhagic Transformation Safety of iv Rt-PA in Wake up Stroke Patients [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 90-day Modified Rankin Scale (mRS) Score 0 or 1 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.

  • Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2010
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: off label rt-PA used
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.
Other Names:
  • Activase®
  • Alteplase
  • tissue plasminogen activator
  • t-PA

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183533

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Colorado
Swedish Medical Center
Englewood, Colorado, United States, 80113
United States, Texas
UT-Houston Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Genentech, Inc.
Investigators
Principal Investigator: Sean I Savitz, MD UT-Houston Health Science Center
Principal Investigator: Andrew D Barreto, MD Study Co-PI
  More Information

No publications provided

Responsible Party: Sean Savitz, MD, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01183533     History of Changes
Other Study ID Numbers: HSC-MS-10-0195
Study First Received: August 16, 2010
Results First Received: October 28, 2014
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Wake-Up Stroke
Ischemic stroke
ischemic stroke patients who wake-up with their symptoms

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014