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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Salivary plasminogen activator alpha 1, Desmodus rotundus

Criteria

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