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A Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients

NCT01282242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2017-06-15

Study results available
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Summary

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.

Conditions

  • Acute Stroke

Interventions

DRUG

IV rt-PA

open-label

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • Lee Schwamm

    lead OTHER

Principal Investigators

  • Lee Schwamm, MD · Massachusetts General Hospital

  • Steven Warach, MD, PhD · NINDS/Seton/UT Southwestern Clinical Research Institute of Austin

  • Ona Wu, PhD · Massachusetts General Hospital

  • Lawrence Latour, PhD · NIH Intramural Stroke Program/Suburban Hospital/Washington Hospital Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-01-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01282242 on ClinicalTrials.gov