Pilot randomized trial of tissue plasminogen activator in acute ischemic stroke

Completed

Phase N/A Results

Trial Description

To assess the efficacy of early thrombolytic therapy with recombinant tissue-type plasminogen activator in the treatment of acute ischemic stroke and to assess the feasibility of conducting a larger, multi-center trial.

Interventions

Trial Design

Randomized, stratified, double-blind, placebo-controlled trial of 27 patients. Stratification was by whether treatment was begun within 90 minutes or 91 to 180 minutes from onset.

Patient Involvement

Patients were randomized to receive either 0.85 mg/kg r-TPA of placebo.

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients in each group who improved by 4 or more points on the National Institutes of Health Stroke Scale at 24 hours.