This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    NCT01282242
Previous Study | Return to List | Next Study

A Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients (MR WITNESS)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Information provided by (Responsible Party):
Lee Schwamm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01282242
First received: January 19, 2011
Last updated: May 24, 2017
Last verified: May 2017
Results First Received: February 27, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Acute Stroke
Intervention: Drug: IV rt-PA

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited between January 2011 and February 2016 from 14 sites across the continental United States, and enrolled in 10 of those sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects diagnosed with acute ischemic stroke, last known well within 24 hours of triage and able to receive IV rt-PA within 4.5 hours from symptom discovery based on MRI findings consistent with early stroke onset, were eligible. MRI Signal Intensity Ration values were defined as <1.15 for the primary and <1.25 for the secondary arm of the trial.

Reporting Groups
  Description
Primary SIR <1.15 MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
Secondary SIR <1.25 MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)

Participant Flow:   Overall Study
    Primary SIR <1.15   Secondary SIR <1.25
STARTED   80   8 
COMPLETED   80   8 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population consists of all subjects enrolled who suffered an unwitnessed stroke and qualified per AHA guidelines to receive IV tPA within a window of 3-4.5 hours since symptom discovery and whose signal intensity ratio (SIR) on MRI was <1.15 for primary arm and <1.25 for secondary arm.

Reporting Groups
  Description
SIR <1.15 MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
SIR <1.25 MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
Total Total of all reporting groups

Baseline Measures
   SIR <1.15   SIR <1.25   Total 
Overall Participants Analyzed 
[Units: Participants]
 80   8   88 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.46  (13.5)   67.13  (11.63)   67.43  (13.26) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  46.3%      4  50.0%      41  46.6% 
Male      43  53.8%      4  50.0%      47  53.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      6   7.5%      0   0.0%      6   6.8% 
Not Hispanic or Latino      73  91.3%      8 100.0%      81  92.0% 
Unknown or Not Reported      1   1.3%      0   0.0%      1   1.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.3%      0   0.0%      1   1.1% 
Asian      2   2.5%      1  12.5%      3   3.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      28  35.0%      5  62.5%      33  37.5% 
White      47  58.8%      2  25.0%      49  55.7% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   2.5%      0   0.0%      2   2.3% 
NIH Stroke Scale (NIHSS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 9.31  (5.87)   10.13  (4.64)   9.35  (5.91) 
[1] NIH Stroke Scale measured the severity of the stroke. The scores ranged between 4 to 42, with higher score indicating worsening of the Outcome. NIHSS score above 20 is indicative of severe stroke.
Modified Rankin Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.48  (1.09)   1.38  (2.26)   1.18  (1.72) 
[1] Modified Rankin Scale (mRS) measures a subjects degree of disability on a scale of 0 to 6, where 0 is no disability and 6 is death.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Symptomatic Intracerebral Hemorrhage   [ Time Frame: Within 7 days from tPA administration. ]

2.  Secondary:   Number of Subjects With Symptomatic Cerebral Edema   [ Time Frame: Within 96 hours of tPA administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This was a single arm open label trial. Genetech provided alteplase free of charge for this NINDS sponsored study.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lee H. Schwamm, MD
Organization: Massachusetts General Hospital
phone: 617-724-1597
e-mail: lschwamm@mgh.harvard.edu



Responsible Party: Lee Schwamm, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01282242     History of Changes
Other Study ID Numbers: 2010P001880
Study First Received: January 19, 2011
Results First Received: February 27, 2017
Last Updated: May 24, 2017