Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

Phase 3

Terminated

Brief Summary: 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 to 9 hours from onset of stroke symptoms.

Detailed Description: 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 to 9 hours after onset of stroke symptoms.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of acute ischemic stroke
Informed consent
Age between 18 and 85 years
Treatment can be initiated within 3 to 9 hours after the onset of stroke symptoms
NIHSS Score of 4 to 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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Desmoteplase	Desmoteplase	-

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)	Day 90	The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient's function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke

Secondary Outcome Measures

Name	Time	Method
Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)	Day 90	Please see outcomes measure one and two for detailed description of the scales
Modified Ranking Scale Score (Using the Ordinal Scale)	Day 90	Please see outcomes measure one for detailed description of the mRS scale
National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)	90 days	The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.

Locations (152): US053
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Phoenix, Arizona, United States
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Castro Valley, California, United States
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La Jolla, California, United States
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Loma Linda, California, United States
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Los Angeles, California, United States
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Palo Alto, California, United States
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Pasadena, California, United States
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Santa Barbara, California, United States
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Thousand Oaks, California, United States
US068
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Englewood, Colorado, United States
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US053
🇺🇸Phoenix, Arizona, United States