Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion (MITI-IA)

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. Identifier: NCT00123266
Recruitment Status : Terminated (Sponsor's decision not to pursue development of uPLi for vascular conditions.)
First Posted : July 22, 2005
Last Update Posted : April 7, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Microplasmin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
Study Start Date : December 2006
Primary Completion Date : July 2007
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ocriplasmin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active Drug: Microplasmin
2 mg/kg, IA over 75 mins

Primary Outcome Measures :
  1. Recanalization rate [ Time Frame: Day-7, Day-30 and Day-90 ]

Secondary Outcome Measures :
  1. Clinical assessment [ Time Frame: Day-7, Day-30 and Day-90 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with angiographically documented vertebrobasilar artery occlusion
  2. Initiation of study drug treatment within 24 hours of the onset of neurological symptoms
  3. Age 18-75 (inclusive).

Exclusion Criteria:

  1. 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
  2. Rapidly improving neurologic signs at any time before initiation of study drug administration.
  3. Known contrast agent-sensitivity
  4. 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.
  5. History of stroke within the previous 6 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00123266

Universitätsklinikum Erlangen
Erlangen, Germany, D-91054
Universitatsklinikum Freiburg
Freiburg, Germany, D-79106
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
UKSH Campus Kiel
Kiel, Germany, 24105
Ludwig-Maximilians-University Hospital
Munich, Germany
HSK Dr. Horst Schmidt Hospital
Wiesbaden, Germany, 65199
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM
Sponsors and Collaborators
Principal Investigator: Gerhard Hamann, Prof. Dr HSK Dr. Horst Schmidt Hospital

Responsible Party: ThromboGenics Identifier: NCT00123266     History of Changes
Other Study ID Numbers: TG-M-003
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014

Keywords provided by ThromboGenics:
Acute vertebrobasilar artery occlusion

Additional relevant MeSH terms:
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action