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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
Results First Submitted: February 27, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Stroke
Intervention: Drug: IV rt-PA

  Participant Flow
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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
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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
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Time Frame Adverse events were collected from the time subjects were consented through study completion, a 90 day period, about 3 months.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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)

Other Adverse Events
    SIR <1.15   SIR <1.25
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   56/80 (70.00%)   8/8 (100.00%) 
Gastrointestinal disorders     
Constipation * 1     
# participants affected / at risk   7/80 (8.75%)   1/8 (12.50%) 
Nausea * 1     
# participants affected / at risk   8/80 (10.00%)   1/8 (12.50%) 
Vomiting * 1     
# participants affected / at risk   6/80 (7.50%)   0/8 (0.00%) 
General disorders     
Pyrexia * 1     
# participants affected / at risk   8/80 (10.00%)   0/8 (0.00%) 
GINGIVAL BLEEDING * 1     
# participants affected / at risk   0/80 (0.00%)   1/8 (12.50%) 
Infections and infestations     
Urinary Tract Infection * 1     
# participants affected / at risk   12/80 (15.00%)   0/8 (0.00%) 
Injury, poisoning and procedural complications     
HEAD INJURY * 1     
# participants affected / at risk   0/80 (0.00%)   1/8 (12.50%) 
LIMB INJURY * 1     
# participants affected / at risk   0/80 (0.00%)   1/8 (12.50%) 
Metabolism and nutrition disorders     
HYPOGLYCAEMIA * 1     
# participants affected / at risk   0/80 (0.00%)   1/8 (12.50%) 
Musculoskeletal and connective tissue disorders     
MUSCLE SPASMS * 1     
# participants affected / at risk   1/80 (1.25%)   1/8 (12.50%) 
OROPHARYNGEAL PAIN * 1     
# participants affected / at risk   0/80 (0.00%)   1/8 (12.50%) 
Nervous system disorders     
Cerebral Haemorrhage * 1     
# participants affected / at risk   4/80 (5.00%)   0/8 (0.00%) 
Heamorrhagic Transformation * 1     
# participants affected / at risk   18/80 (22.50%)   1/8 (12.50%) 
Headache * 1     
# participants affected / at risk   13/80 (16.25%)   0/8 (0.00%) 
Amnesia * 1     
# participants affected / at risk   0/80 (0.00%)   1/8 (12.50%) 
Psychiatric disorders     
Agitation * 1     
# participants affected / at risk   4/80 (5.00%)   0/8 (0.00%) 
Depression * 1     
# participants affected / at risk   4/80 (5.00%)   0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
ATELECTASIS * 1     
# participants affected / at risk   0/80 (0.00%)   1/8 (12.50%) 
Skin and subcutaneous tissue disorders     
Ecchymosis * 1     
# participants affected / at risk   5/80 (6.25%)   0/8 (0.00%) 
Petechiae * 1     
# participants affected / at risk   4/80 (5.00%)   2/8 (25.00%) 
INJECTION SITE EXTRAVASATION * 1     
# participants affected / at risk   1/80 (1.25%)   1/8 (12.50%) 
Vascular disorders     
ATRIAL FIBRILLATION * 1     
# participants affected / at risk   0/80 (0.00%)   1/8 (12.50%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (16.1)



  Limitations and Caveats
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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
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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
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