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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
Genentech
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: May 7, 2013
Last verified: May 2013
  Purpose

The purpose is to demonstrate the safety of IV t-PA in ischemic stroke patients who present to the ED after awakening with the symptoms of suspected ischemic stroke.


Condition Intervention Phase
Ischemic Stroke
Drug: Alteplase (iv t-PA)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy 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 t-PA in wake up stroke patients [ Time Frame: 24 hr ] [ 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.


Secondary Outcome Measures:
  • Clinical improvement [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]
    Clinical improvement defined as a decrease in the NIHSS score at 24 hours, 3 days and 90 days and modified Rankin at 3 days and 90 days.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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 NIHSS score at 24 hours, 3 days and 90 days and modified Rankin at 3 days and 90 days. For patients that have CTA and 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 ≤25
  • BP ≤185 mmHg systolic & ≤110 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment
  • t-PA must be given within 3 hrs 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 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 PTT
  • Oral anticoagulants & an 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 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

Contacts
Contact: Jennifer M Garrett, RN 713-500-7183 jennifer.m.garrett@uth.tmc.edu

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Andre Alexandrov, MD         
Principal Investigator: Andre Alexandrov, MD         
United States, Colorado
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Chris Fanale, MD         
Principal Investigator: Chris Fanale, MD         
United States, Texas
UT-Houston Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Jennifer M Garrett, RN    713-500-7183    jennifer.m.garrett@uth.tmc.edu   
Principal Investigator: Sean I Savitz, MD         
Sub-Investigator: Andrew Barreto, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Genentech
Investigators
Principal Investigator: Sean I Savitz, MD UT-Houston Health Science Center
Principal Investigator: Andrew 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
Last Updated: May 7, 2013
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:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 23, 2014