AN OPEN-LABEL CLINICAL TRIAL OF INTRA-ARTERIAL MICROPLASMIN ADMINISTRATION IN PATIENTS WITH ACUTE INTRACRANIAL VERTEBROBASILAR ARTERY OCCLUSIO

Phase 2

Withdrawn

Conditions: Acute ischemic stroke
closed cerebral blood vessel
10014523

Registration Number: NL-OMON31313

Lead Sponsor: Thrombogenics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 4

Inclusion Criteria

1. New neurologic signs in the vertebrobasilar artery distribution allowing initiation of study drug treatment within 24 hours of the onset of neurological symptoms (loss of consciousness, dysarthria, anarthria, hemianopia, tetraparesis, tetraplegia, bilateral Babinski sign, dysphagia, double vision, nystagmus); other non-specific neurological symptoms such as dizziness, headache, vomiting, nausea are not restricted to the 24 hour time window
2. Patients with angiographically documented vertebrobasilar artery occlusion
3. Age 18-75 (inclusive).
4. Women of child-bearing potential must have a negative pregnancy test prior to enrolment and be using a reliable form of contraception
5. For conscious patients, prior to inclusion in the study and following a full explanation of the nature and purpose of the study, the patient or the patient*s legal representative must consent/assent to participate by signing the Informed Consent document.

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.
6. Seizures at any time between stroke onset to planned initiation of study drug.
7. History of intracranial hemorrhage
8. History of surgery, lumbar puncture, biopsy or trauma to internal organs within the previous 30 days.
9. Head trauma within the previous 90 days.
10. Known bleeding diathesis.
11. Baseline INR >1.7 or baseline APTT > 2 times normal
12. Baseline platelet count < 100 X 10 9/L.
13. Hypodensity on CT or diffusion abnormality on MRI of greater than half the brain stem
14. Blood glucose > 400mg/dl
15. Patients who have received intra-arterial or systemic thrombolytic therapy within the 7 days prior to the study.
16. Patients who have received tPA or any other thrombolytic agent for the qualifying stroke.
17. Patients receiving vitamin-K antagonists or heparin which results in either an INR>1.4 or an aPTT>2 times control (ULN for the hospital laboratory), respectively. 18. Patients who have received glycoprotein IIb/IIIa inhibitors within 48 hours prior to enrolment.
19. Patients who have received more than one dose of low molecular weight heparin within 48 hours prior to enrolment.
20. Participation in another study with an investigational drug or device within the previous 30 days, prior participation in the present study, or planned participation in another trial within the timeframe of the current trial
21. Life expectancy <3 months
22. Other serious illness that in the opinion of the investigator may confound clinical assessment (eg hepatic, cardiac, or renal failure, advanced cancer)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>EFFICACY:<br /><br>Proportion of patients achieving recanalization of the basilar artery.<br /><br><br /><br>SAFETY parameters:<br /><br>-Intracranial hemorrhage<br /><br>-Major bleeding<br /><br>-Bleeding other than major<br /><br>-Reocclusion at 48 hr after initiation of study drug (as determined by CT<br /><br>angiography)<br /><br>-Serious and non-serious adverse events<br /><br>-Allergic reactions<br /><br>-Immunology (Microplasmin and Staphylokinase antibody assays)<br /><br>-Laboratory data<br /><br>-Markers of systemic lysis and complement activation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>EFFICACY:<br /><br>-Duration of study drug administration to achieve recanalization<br /><br>-Proportion of patients achieving TIMI 3 and TIMI 2 or 3 grade at the end of<br /><br>study drug administration<br /><br>-Clinical outcome as assessed by survival and neurologic rating scales at 7<br /><br>days, 30 and 90 days post-treatment.<br /><br><br /><br>ADDITIONAL:<br /><br>-Pharmacokinetic measurements.<br /><br>-Pharmacodynamic measurements (a2-antiplasmin).</p><br>

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