Back to resultsIntra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion (MITI-IA)
Primary Purpose
Stroke
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Microplasmin
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, vertebrobasilar, basilar, Acute vertebrobasilar artery occlusion
Eligibility Criteria
Inclusion Criteria: Patients with angiographically documented vertebrobasilar artery occlusion Initiation of study drug treatment within 24 hours of the onset of neurological symptoms Age 18-75 (inclusive). Exclusion Criteria: Patients with coma > 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation Rapidly improving neurologic signs at any time before initiation of study drug administration. Known contrast agent-sensitivity Uncontrolled hypertension defined as a systolic blood pressure > 180 mm Hg or a diastolic blood pressure > 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy. History of stroke within the previous 6 weeks.
Sites / Locations
- Universitätsklinikum Erlangen
- Universitatsklinikum Freiburg
- Universitätsklinikum des Saarlandes
- UKSH Campus Kiel
- Ludwig-Maximilians-University Hospital
- HSK Dr. Horst Schmidt Hospital
- Sint Antonius Ziekenhuis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
Outcomes
Primary Outcome Measures
Recanalization rate
Secondary Outcome Measures
Clinical assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00123266
Brief Title
Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
Acronym
MITI-IA
Official Title
An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision not to pursue development of uPLi for vascular conditions.
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.
Detailed Description
Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, vertebrobasilar, basilar, Acute vertebrobasilar artery occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Microplasmin
Intervention Description
2 mg/kg, IA over 75 mins
Primary Outcome Measure Information:
Title
Recanalization rate
Time Frame
Day-7, Day-30 and Day-90
Secondary Outcome Measure Information:
Title
Clinical assessment
Time Frame
Day-7, Day-30 and Day-90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with angiographically documented vertebrobasilar artery occlusion
Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
Age 18-75 (inclusive).
Exclusion Criteria:
Patients with coma > 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation
Rapidly improving neurologic signs at any time before initiation of study drug administration.
Known contrast agent-sensitivity
Uncontrolled hypertension defined as a systolic blood pressure > 180 mm Hg or a diastolic blood pressure > 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.
History of stroke within the previous 6 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Hamann, Prof. Dr
Organizational Affiliation
HSK Dr. Horst Schmidt Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
D-91054
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
UKSH Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Ludwig-Maximilians-University Hospital
City
Munich
Country
Germany
Facility Name
HSK Dr. Horst Schmidt Hospital
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Sint Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
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