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

This study has been terminated.
(Sponsor's decision not to pursue development of uPLi for vascular conditions.)
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00123266
First received: July 21, 2005
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Stroke
Drug: Microplasmin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • Recanalization rate [ Time Frame: Day-7, Day-30 and Day-90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical assessment [ Time Frame: Day-7, Day-30 and Day-90 ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: December 2006
Study Completion Date: August 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: Microplasmin
2 mg/kg, IA over 75 mins

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123266

Locations
Germany
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
Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM
Sponsors and Collaborators
ThromboGenics
Investigators
Principal Investigator: Gerhard Hamann, Prof. Dr HSK Dr. Horst Schmidt Hospital
  More Information

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00123266     History of Changes
Other Study ID Numbers: TG-M-003
Study First Received: July 21, 2005
Last Updated: April 4, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by ThromboGenics:
stroke
vertebrobasilar
basilar
Acute vertebrobasilar artery occlusion

ClinicalTrials.gov processed this record on October 19, 2014