Intra-Arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion - Full Text View

Sponsored by:	ThromboGenics
Information provided by:	ThromboGenics
ClinicalTrials.gov Identifier:	NCT00123266

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 II

Drug Information available for: Microplasmin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Clinical Trial of Intra-Arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion

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
1: Experimental	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:

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.

Contacts and Locations

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

Locations

Germany
HSK Dr. Horst Schmidt Hospital
Wiesbaden, Germany, 65199
Ludwig-Maximilians-University Hospital
Munich, Germany
UniversitÃ¤tsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
UniversitÃ¤tsklinikum Erlangen
Erlangen, Germany, D-91054
UKSH Campus Kiel
Kiel, Germany, 24105
Universitatsklinikum Freiburg
Freiburg, Germany, D-79106
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

Responsible Party:	ThromboGenics ( Saskia Cremers )
Study ID Numbers:	TG-M-003
Study First Received:	July 21, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00123266
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

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009