Stroke Trials Registry

ASK
Australian Streptokinase Trial

Principal Investigator
Donnan, GA

PI Address
Austin and Repatriation Medical Centre, Heidelberg, Victoria, Australia.

Contact Address
Geoffrey A. Donnan, MD, Austin and Repatriation Medical Centre, Heidelberg, Victoria 3084, Australia

Trial Phase:	Phase III
Study Size Actual:	340
Centers Actual:	40
Max Time from onset:	4 Hours
Max Age:	85
Min Age:	18

Status:
Trial complete. Results published 9/96.

Purpose:
To determine whether the administration of 1.5 million units of streptokinase intravenously within 4 hours of the onset of acute ischemic stroke would reduce morbidity and mortality at 3 months and whether outcomes may be better for those receiving therapy within 3 hours of stroke onset compared with those receiving it after 3 hours.

Interventions:

Streptokinase
Thrombolytic agent

Location(s):
Australia

Year Published: 1996

Design:
Randomized, double-blind, placebo-controlled trial involving 340 patients at 40 centers throughout Australia.

Inclusion Criteria
Between the ages of 18 and 85, acute ischemic stroke presenting within 4 hours of onset.

Exclusion Criteria
Mild neurological deficit, anticoagulants given within 48 hours of stroke onset, streptokinase given for reasons other than stroke within the previous 12 months, acute stroke occurring within the previous 3 months, previous stroke present in the same hemisphere that might interfere with the neurological assessment, active peptic ulcer disease, major trauma within the preceding 3 months or surgery within the previous 10 days, pregnancy, childbirth within the past 4 weeks, uncontrolled hypertension, severe systemic disease with poor prognosis, proliferative diabetic retinopathy, or recovery prior to registration of a neurological deficit with a CNS greater than 9.0.

Patient Involvement:
Administration of 1.5 million units of streptokinase or placebo intravenously in 100 mL of normal saline over 1 hour with 3 month follow-up.

Primary Outcome:
Combined death and disability score (Barthel index <60) 3 months after the stroke.

Results:
The study found a nonsignificant trend toward unfavorable outcomes for streptokinase vs placebo and an excess of hematomas in the treated group,. Poor outcomes were confined to patients receiving therapy more than 3 hours after stroke onset. Streptokinase administration resulted in excess deaths in the group treated after 3 hours but not among those treated within 3 hours.

Source of Information:
JAMA 1996 Sep 25;276(12):961-6

Web Links and Publications:

Baseline blood pressure but not early computed tomography changes predicts major hemorrhage after streptokinase in acute ischemic stroke
Stroke 2002 Sep;33(9):2236-42

Streptokinase in acute stroke: effect on reperfusion and recanalization. Australian Streptokinase Trial Study Group.
Neurology 1998 Mar;50(3):626-32

Streptokinase for acute ischemic stroke with relationship to time of administration: Australian Streptokinase (ASK) Trial Study Group.
JAMA 1996 Sep 25;276(12):961-966

This information last updated on: 10/5/2000

UID: 116