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

Lundbeck

Status and phase

Terminated

Phase 3

Conditions

Stroke

Treatments

Drug: Desmoteplase

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00856661

2008-005539-14 (EudraCT Number)

12649A

Details and patient eligibility

About

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.

Full 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.

Enrollment

270 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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