Australian Urokinase Stroke Trial "AUST"

Suspended

Phase N/A Results N/A

Trial Description

To compare the efficacy of urokinase in combination with heparin with that of heparin alone in reducing the morbidity and mortality in patients with ischemic stroke and lysable lesions.

Interventions

Trial Design

Randomized, blinded study of approximately 200 patients.

Patient Involvement

All patients initially received 5000 IU of intraarterial heparin. Patients were then randomized to either a treatment or a control group. The treatment group received incremental doses of intraarterial urokinase every 10-15 minutes up to a maximum total dose of 1 million IU. Patients in the control group received no further intervention during this time period. Following this phase of the treatment protocol, all patients received a 24-hour infusion of intravenous heparin. Further therapy was adjusted to maintain the activated partial thromboplastin time (APTT) at 60-80 for at least 48 hours. All patients underwent digital subtraction angiography after each bolus dose, and received neurological examinations between days 7 and 10, and at discharge. All patients underwent CT scanning, and magnetic resonance angiography (MRA) between days 7 and 10, and received APTT evaluation according to local practice. Patients were evaluated at 3 and 6 months by a blinded investigator who performed a physical examination, a neurological examination to determine the NIH Stroke Scale Score, who evaluated their functional status by assigning Barthel Index and Modified Rankin Scale Scores, who recorded the incidence of any adverse events, and documented patterns of health care utilization.

Outcomes

Type Measure Time Frame Safety Issue
Primary Morbidity and mortality at 6 months.

Sponsors

The Serono company has withdrawn its sponsorship. Alternative sponsorship is being sought.