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, 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: May 7, 2013
Last verified: May 2013

August 16, 2010
May 7, 2013
September 2010
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01183533 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Safety of Intravenous Thrombolysis for Wake-up Stroke
Safety of Intravenous Thrombolysis for Wake-up Stroke

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ischemic Stroke
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
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.
Intervention: Drug: Alteplase (iv t-PA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Jennifer M Garrett, RN 713-500-7183 jennifer.m.garrett@uth.tmc.edu
United States
 
NCT01183533
HSC-MS-10-0195
Yes
Sean Savitz, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Genentech, Inc.
Principal Investigator: Sean I Savitz, MD UT-Houston Health Science Center
Principal Investigator: Andrew Barreto, MD Study Co-PI
The University of Texas Health Science Center, Houston
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP