Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion

Stroke Clinical Trial

— MITI-IA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00123266
• Other study ID #: TG-M-003
• Status: Terminated
• Phase: Phase 2
• First received: July 21, 2005
• Last updated: April 4, 2014
• Start date: December 2006
• Est. completion date: August 2008

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Microplasmin
2 mg/kg, IA over 75 mins

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	UKSH Campus Kiel	Kiel
Germany	Ludwig-Maximilians-University Hospital	Munich
Germany	HSK Dr. Horst Schmidt Hospital	Wiesbaden
Netherlands	Sint Antonius Ziekenhuis	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recanalization rate		Day-7, Day-30 and Day-90	No
Secondary	Clinical assessment		Day-7, Day-30 and Day-90	No