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

April 4, 2014 updated by: ThromboGenics

An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, D-91054
        • Universitätsklinikum Erlangen
      • Freiburg, Germany, D-79106
        • Universitätsklinikum Freiburg
      • Homburg/Saar, Germany, 66421
        • Universitätsklinikum des Saarlandes
      • Kiel, Germany, 24105
        • UKSH Campus Kiel
      • Munich, Germany
        • Ludwig-Maximilians-University Hospital
      • Wiesbaden, Germany, 65199
        • HSK Dr. Horst Schmidt Hospital
  • Netherlands
      • Nieuwegein, Netherlands, 3430 EM
        • Sint Antonius Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recanalization rate
Time Frame: Day-7, Day-30 and Day-90
Day-7, Day-30 and Day-90

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical assessment
Time Frame: Day-7, Day-30 and Day-90
Day-7, Day-30 and Day-90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThromboGenics

Investigators

  • Principal Investigator: Gerhard Hamann, Prof. Dr, HSK Dr. Horst Schmidt Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

July 21, 2005

First Submitted That Met QC Criteria

July 21, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-M-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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