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Trial record 1 of 1 for:    NCT01282242
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A Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients (MR WITNESS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01282242
First Posted: January 24, 2011
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Information provided by (Responsible Party):
Lee Schwamm, Massachusetts General Hospital
  Purpose

This study was jointly developed and is jointly led by investigators at Massachusetts General Hospital and the intramural division of NINDS. We are doing this research study to find out if Activase ® (also called alteplase or rt-PA) can safely be given to people with an acute ischemic stroke when their stroke onset was not witnessed making them ineligible for standard thrombolytic (clot busting) therapy. We also want to find out if rt-PA can help people recover better from their stroke.

The purpose of this study is to: 1) see if it is safe to give intravenous (IV) rt-PA to people with unwitnessed stroke but with MRI evidence of early ischemic stroke, 2) see if rt-PA is effective if given to people who are selected for treatment based on MRI evidence of an early stroke, and 3) get information about this new MRI diagnostic methods for guiding stroke treatment.


Condition Intervention Phase
Acute Stroke Drug: IV rt-PA Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MR WITNESS: A Phase IIa Safety Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients

Resource links provided by NLM:


Further study details as provided by Lee Schwamm, Massachusetts General Hospital:

Primary Outcome Measures:
  • Number of Subjects With Symptomatic Intracerebral Hemorrhage [ Time Frame: Within 7 days from tPA administration. ]
    Safety of IV rt-PA as evident by rates of symptomatic ICH defined by an increase of 4 points or more on the NIHSS .


Secondary Outcome Measures:
  • Number of Subjects With Symptomatic Cerebral Edema [ Time Frame: Within 96 hours of tPA administration ]
    Safety of IV rt-PA as evident by rates of symptomatic cerebral edema defined as brain edema with mass effect as the predominant cause of clinical deterioration.


Enrollment: 88
Study Start Date: January 2011
Study Completion Date: May 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV rt-PA
open-label
Drug: IV rt-PA
open-label
Other Name: Alteplase, Activase

Detailed Description:
This study was jointly developed and is jointly led by Massachusetts General Hospital and the NINDS. This is a multi-center, open-label, Phase IIa safety study in adult acute ischemic stroke patients to determine if it is safe to extend intravenous thrombolytic treatment to subjects who are evaluated within 24 hours from last known well ("stroke onset") and eligible to receive thrombolytic treatment within 4.5 hours from symptom discovery with the assistance of an MRI-based "witness" when no human witness of stroke onset is available. The study is designed to investigate the safety in using standard diagnostic MRI in selecting patients for thrombolytic therapy when the last known well time places the patient beyond the current IV thrombolytic time-window.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age, 18 to 85 years inclusive
  • Brain MRI findings consistent with early stroke onset
  • Clinical diagnosis of acute ischemic stroke with disabling neurological deficit
  • Stroke symptoms present for at least 30 minutes with no significant improvement before treatment
  • Be last known well (without stroke symptoms) within 24 hours of triage
  • Be able to receive IV rt-PA within 4.5 hours from the time the symptoms were discovered.
  • MRI diagnostic of acute ischemic stroke and consistent with clinical syndrome
  • Time between completion of qualifying MRI studies to treatment initiation ≤ 1 hour

Exclusion Criteria:

  • History of intracranial hemorrhage
  • Symptoms rapidly improving or only minor before start of study drug.
  • Severe stroke as assessed clinically (e.g., NIHSS score >25) or by appropriate imaging techniques (lesion volume > one-third of MCA by visual inspection or >100 cm3 using the ellipsoid estimation formula of ABC/2)
  • Stroke or serious head trauma within the previous 3 months
  • Administration of heparin within the 48 hours preceding the onset of stroke, with an activated partial-thromboplastin time at presentation exceeding the upper limit of the normal range
  • Platelet count of less than 100,000 per cubic millimeter
  • Uncontrolled hypertension defined as systolic blood pressure > 185 mm Hg or diastolic blood pressure > 110 mm Hg that cannot be controlled except with continuous parenteral antihypertensive medication
  • Blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT/MRI scan was normal
  • Oral anticoagulant treatment, regardless of INR.
  • Major surgery or severe trauma within the previous 3 months
  • Other major disorders associated with an increased risk of bleeding
  • Eligible for rt-PA therapy per institutional protocol as part of routine clinical practice
  • Non-ischemic etiology demonstrated by neuroimaging
  • Neuroimaging (CT or gradient echo MRI) evidence of acute or chronic ICH (non-microbleed)
  • Presence of 10 or more microbleeds on GRE (suggestive of amyloid angiopathy)
  • Any contraindication for MRI, e.g. presence of a pacemaker, ferromagnetic aneurysm clip, etc, pre-menopausal women with a positive pregnancy blood test, or severe claustrophobia.
  • Poor quality MRI- images are not interpretable
  • In the opinion of the investigator, the patient is not an appropriate candidate for IV rt-PA
  • Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282242


Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
NIH/ NINDS, Washington Hospital, Suburban Hospital
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Missouri
Washington University School of Medicine/Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38105
United States, Texas
Seton/UT Southwestern Medical Center
Austin, Texas, United States, 78701
United States, Utah
Intermountain Healthcare
Murray, Utah, United States, 84107
Sponsors and Collaborators
Lee Schwamm
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Investigators
Principal Investigator: Lee Schwamm, MD Massachusetts General Hospital
Principal Investigator: Steven Warach, MD, PhD NINDS/Seton/UT Southwestern Clinical Research Institute of Austin
Principal Investigator: Ona Wu, PhD Massachusetts General Hospital
Principal Investigator: Lawrence Latour, PhD NIH Intramural Stroke Program/Suburban Hospital/Washington Hospital Center
  More Information

Responsible Party: Lee Schwamm, Vice Chairman, Department of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01282242     History of Changes
Other Study ID Numbers: 2010P001880
First Submitted: January 19, 2011
First Posted: January 24, 2011
Results First Submitted: February 27, 2017
Results First Posted: April 11, 2017
Last Update Posted: June 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lee Schwamm, Massachusetts General Hospital:
acute stroke, IV rt-PA, Activase, Alteplase

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action