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.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• Clinical diagnosis of acute ischemic stroke
• Male or female between 18 and 85 years of age inclusive.
• Treatment of the subject can be initiated within 3-9 hours after the onset of stroke symptoms.
• The subject has a score of 4-24 inclusive on the NIHSS with clinical signs of hemispheric infarction (for example, hemiparesis)
• The subject shows occlusion or high-grade stenosis as assessed by MRA or CTA in proximal cerebral arteries that correspond to the acute clinical deficit.
• The subject should receive IMP within 60 minutes after completion of diagnostic imaging screening

Exclusion Criteria

• The subject has a pre-stroke mRS > 1 indicating previously disability
• The subject has previously been exposed to desmoteplase
• The subject shows signs of extensive early infarction on MRI or CT in any affected area
• The subject has imaging evidence of ICH or SAH (regardless of age of the bleeding)
• The subject has an internal carotid artery occlusion on the side of the stroke lesion
• The subject has been treated with heparin in the past 48 hours and has a prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
• The subject is on oral anticoagulants and has a prolonged prothrombin time (INR > 1.6)
• The subject has been treated with glycoprotein IIb - IIIa inhibitors within the past 72 hours.
• The subject has been treated with factor Xa inhibitors in the past 72 hours
• The subject has been treated with a thrombolytic agent within the past 72 hours

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

A randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed-dose study evaluating the efficacy and safety of three dosages of Lu AA21004, in acute treatment of Major Depressive Disorder. - Not applicable

H. Lundbeck A/S

Updated 8/17/2015

A randomised, double-blind, parallel-group, placebo-controlled and active-referenced study evaluating the efficacy and safety of three fixed dose regimens of Lu AA34893 in the treatment of Major Depressive Disorder.

H. Lundbeck A/S

Updated 7/3/2012

A randomised, double-blind, parallel-group, placebo controlled study ofesomeprazole i.v. (bolus infusion of 80 mg followed by a continuous infusionof 8 mg per hour) administered for 72 hours to assess prevention ofrebleeding in subjects that have undergone successful primary endoscopichaemostasis of a bleeding peptic ulcer – the PUB study - NA

AstraZeneca AB

Updated 5/20/2013

A randomised, double-blind, parallel-group, placebo-controlled and active-referenced study evaluating the efficacy and safety of three fixed dose regimens of Lu AA34893 in the treatment of Major Depressive Disorder.

H. Lundbeck A/S

Updated 7/3/2012

A randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed-dose study evaluating the efficacy and safety of three dosages of Lu AA21004, in acute treatment of Major Depressive Disorder. - Not applicable

Phase 1

H. Lundbeck A/S

Updated 10/8/2021

A randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed-dose study evaluating the efficacy and safety of Lu AA21004 (15 and 20 mg/day) in the acute treatment of adult patients with Major Depressive Disorder.

H. Lundbeck A/S

Updated 10/22/2012