Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

Phase 3

Completed

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: Desmoteplase

• Registration Number: NCT00790920
• Lead Sponsor: H. Lundbeck A/S

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 3-9 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 3-9 hours after onset of stroke symptoms.

Study Timeline

• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Study Start: 2008-12
• Primary Completion: 2014-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 492

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Desmoteplase	Desmoteplase	-

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale Score	90 days

Secondary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale (NIHSS) Score	90 days

Trial Locations

Locations (102)

AU006; 🇦🇺 Clayton, Australia

AU004; 🇦🇺 Gosford, Australia

AU001; 🇦🇺 Melbourne, Australia

AU002; 🇦🇺 Melbourne, Australia

AU003; 🇦🇺 New Castle, Australia

AU009; 🇦🇺 Perth, Australia

AT003; 🇦🇹 Graz, Austria

AT004; 🇦🇹 Innsbruck, Austria

AT002; 🇦🇹 Linz, Austria

AT001; 🇦🇹 Linz, Austria

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