Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 16, 2010
November 24, 2014
July 2010
October 2013   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01183533 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
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 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.

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.

Interventional
Phase 2
Endpoint Classification: Safety 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.
 
Completed
40
January 2014
October 2013   (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 (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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
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 D Barreto, MD Study Co-PI
The University of Texas Health Science Center, Houston
November 2014

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