Thrombolytic Therapy in Acute Ischemic Stroke Study, Part A "TTAISS"

Completed

Phase 2 Results

Trial Description

To test the efficacy and relative safety of rtPA versus placebo.

Interventions

Trial Design

Placebo-controlled, double-blind, randomized study of 142 patients at 42 centers.

Patient Involvement

Patients were randomized to receive IV rt-PA (0.9 mg/kg) or placebo for one hour.

Outcomes

Type Measure Time Frame Safety Issue
Primary Clinical improvement as measured by a decrease of >=4 points on the National Institutes of Health Stroke Scale (NIHSS) or complete resolution of symptoms from baseline to 21 hours and from baseline to 30 days. Also, the volume of cerebral infarction as measured by CT scan at 30 days.
Secondary Mortality at 90 days and functional outcome as measured by the Barthel Index and modified Rankin scale at days 30 and 90.

Sponsors

Genentech, Inc.