Study Design

Study Design:

Patients Screened: N/A
Patients Enrolled: 310
NYHA Class: N/A
Mean Follow Up: Six months
Mean Patient Age: 22-94
Female: 43
Mean Ejection Fraction: N/A

Patient Populations:

All patients who were hospitalized because of the sudden onset of a focal neurologic deficit attributable to ischemia in the territory of the middle cerebral artery and who could be randomly assigned to a treatment group within six hours after the onset of symptoms were eligible for enrollment.

Exclusions:

The criteria for exclusion were a mild deficit (MAST score >55), the resolution of symptoms before randomization, a computed tomographic scan showing cerebral hemorrhage or a nonvascular disorder, a previous hemorrhagic stroke or a previous stroke with clinical sequelae, recent surgery or trauma, another illness known to compromise prognosis, or known or suspected pregnancy.

Primary Endpoints:

The primary efficacy outcome was a binary criterion combining mortality with severe disability at six months, with severe disability defined as a score of 3 or higher on the Rankin scale. The primary safety outcomes were mortality at 10 days and cerebral hemorrhage.

Secondary Endpoints:

The secondary efficacy outcomes were death, recurrent cerebrovascular events, and ischemic events.

Drug/Procedures Used:

Patients with moderate to severe ischemia in the territory of the middle cerebral artery were randomly assigned to receive streptokinase (1.5 million units over a period of one hour) or placebo within six hours after the onset of stroke.

Concomitant Medications:

The use of concomitant treatments was left to the discretion of the participating investigators. Sixty-five percent of the patients in the streptokinase group and 75% in the placebo group received concomitant treatment with heparin.