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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Genentech
Information provided by (Responsible Party):
Lee Schwamm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01282242
First received: January 19, 2011
Last updated: January 9, 2014
Last verified: January 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • rt-PA Safety [ Time Frame: within 24 hours of last know well and MRI evidence of early stroke ] [ Designated as safety issue: Yes ]
    rt-PA safety as evidenced by no significant increase in symptomatic ICH rates


Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT01282242

Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Janine Terry, MPH    310-967-8571    janine.terry@cshs.org   
Principal Investigator: Shlee Song, MD         
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Judy Guzy    310-794-0600    JGuzy@mednet.ucla.edu   
Principal Investigator: Sidney Starkman, MD         
United States, Maryland
NIH/ NINDS, Washington Hospital, Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20892
Contact: Saman Farsad, MS    301-435-2269    farsads@mail.nih.gov   
Principal Investigator: John M Hallenbeck, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Abigail Cohen    617-724-2829    acohen18@partners.org   
Principal Investigator: Lee Schwamm, MD         
United States, Missouri
Washington University School of Medicine/Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jill Newgent, RN, BSN    314-747-3795    newgentj@neuro.wustl.edu   
Principal Investigator: Andria L Ford, MD         
United States, Texas
Seton/UT Southwestern Medical Center Recruiting
Austin, Texas, United States, 78701
Contact: Delmas McBee, RN    512-324-7000 ext 77744    DMcBee@seton.org   
Principal Investigator: Steven Warach, MD, PhD         
Sponsors and Collaborators
Lee Schwamm
Genentech
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

No publications provided

Responsible Party: Lee Schwamm, Vice Chairman, Department of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01282242     History of Changes
Other Study ID Numbers: MR WITNESS
Study First Received: January 19, 2011
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on July 24, 2014