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:
ThromboGenics
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00123266
First received: July 21, 2005
Last updated: November 14, 2012
Last verified: November 2008
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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:
- 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 | |
| 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: | November 14, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Stroke Arterial Occlusive Diseases Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013