Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

Study Overview
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Brief Summary
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The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.

Detailed Description
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Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity. The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.

Official Title
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A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: Desmoteplase
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of acute ischemic stroke Informed consent Age between 18 and 85 years Treatment can be initiated within 3-9 hours after the onset of stroke symptoms NIHSS Score of 4-24 Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries Exclusion Criteria: Pre-stroke mRS >1 Previous exposure to desmoteplase Extensive early infarction on MRI or CT in any affected area Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm Internal carotid artery occlusion on the side of the stroke lesion Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time Treatment with oral anticoagulants and a prolonged prothrombin time Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted Treatment with a thrombolytic agent within the past 72 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desmoteplase<br> | Drug: Desmoteplase<br>* 90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* IV, single bolus over 1 - 2 minutes on 1st day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale Score |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale (NIHSS) Score |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute ischemic stroke, Angiography, Desmoteplase, Thrombolytic