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

Phase 2

Terminated

• Conditions: Stroke
• Interventions: Drug: Microplasmin

• Registration Number: NCT00123266
• Lead Sponsor: ThromboGenics

Brief 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.

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 Timeline

• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Study Start: 2006-12
• Primary Completion: 2007-07
• Study Completion: 2008-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-04
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	Microplasmin	-

Primary Outcome Measures

Name	Time	Method
Recanalization rate	Day-7, Day-30 and Day-90

Secondary Outcome Measures

Name	Time	Method
Clinical assessment	Day-7, Day-30 and Day-90

Trial Locations

Locations (7)

Universitatsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

HSK Dr. Horst Schmidt Hospital; 🇩🇪 Wiesbaden, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg/Saar, Germany

Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

UKSH Campus Kiel; 🇩🇪 Kiel, Germany

Ludwig-Maximilians-University Hospital; 🇩🇪 Munich, Germany