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


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.


Trial Design

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

Patient Involvement

272 patients received Alteplase and 275 received placebo.


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.


Genentech, Inc.