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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00856661

Run by

H. Lundbeck A/S

People needed

270

Starts

2009-04-01

Last updated by the study team

2017-03-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• US081 — Castro Valley, California, United States
• US089 — La Jolla, California, United States
• US043 — Loma Linda, California, United States
• US008 — Los Angeles, California, United States
• US020 — Palo Alto, California, United States
• US050 — Pasadena, California, United States
• US098 — Santa Barbara, California, United States
• US051 — Thousand Oaks, California, United States
• US068 — Englewood, Colorado, United States
• US063 — Fairfield, Connecticut, United States
• US104 — New Haven, Connecticut, United States
• US049 — Pensacola, Florida, United States
• US109 — Atlanta, Georgia, United States
• US042 — Augusta, Georgia, United States
• US052 — Columbus, Georgia, United States
• US080 — Decatur, Georgia, United States
• US040 — Lawrenceville, Georgia, United States
• US067 — Macon, Georgia, United States
• US085 — Savannah, Georgia, United States
• US086 — Savannah, Georgia, United States
• US093 — Chicago, Illinois, United States
• US101 — Chicago, Illinois, United States
• US044 — Chicago, Illinois, United States
• US074 — Evanston, Illinois, United States
• US053 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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