Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke "ATLANTIS"

Completed

Phase 3 Results

Trial Description

To assess the efficacy and safety of 0.9 mg/kg intravenous rtPA (Alteplase) vs placebo in acute ischemic stroke patients treated within 3 to 5 hours of stroke onset.

Interventions

Trial Design

Placebo-controlled, double-blind, randomized study of 613 patients at 140 centers.

Patient Involvement

272 patients received Alteplase and 275 received placebo.

Outcomes

Type Measure Time Frame Safety Issue
Primary NIH Stroke Scale (NIHSS) score <= 1.
Secondary Barthel Index, modified Rankin scale, and Glasgow Outcome Scale at 30 days and 90. Serious adverse events were also assessed.

Sponsors

Genentech, Inc.