Overview

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