Emergency Management of Stroke Bridging Trial "EMS"

Completed

Phase N/A Results

Trial Description

To test the feasibility, efficacy and safety of combined intravenous (IV) and intraarterial (IA) recombinant tissue plasminogen activator (rt-PA) within 3 hours of stroke symptom onset.

Interventions

Trial Design

Double-blind, randomized, placebo-controlled, multi-center trial involving 36 patients.

Patient Involvement

18 patients were randomized to receive intravenous (IV) rt-PA and 18 received IV placebo followed by immediate cerebral arteriography and local intra-arterial (IA) administration of rt-PA by means of a microcatheter.

Outcomes

Type Measure Time Frame Safety Issue
Primary 7 point improvement on the National Institutes of Health Stroke Scale Score (NIHSSS) at 0, 1 or 7 days.
Secondary Barthel Index, modified Rankin Scale, and Glasgow outcome Scale measured at 3 months; mortality, arterial recanalization rates and their relations to total rt-PA dose and time to lysis, rates of life-threatening bleeding, intracerebral hemorrhage (ICH) or other bleeding complications to assess safety.

Sponsors

Genentech, Inc.