Canadian Activase for Stroke Effectiveness Study "CASES"

Completed

Phase 4 Results

Trial Description

To prospectively evaluate the use of intravenous rt-PA in Canada. Thrombolytic therapy for acute stroke in Canada was conditionally approved in 1999; this study was a mandated by the federal government as a condition for full approval.

Interventions

Trial Design

Open label, multi-center post-marketing study.

Outcomes

Type Measure Time Frame Safety Issue
Primary Clinical outcome at 3 months assessed by the modified Rankin Scale score, ASPECT scores measured by investigators compared with a panel of experts, and symptomatic intracerebral hemorrhage related to rtPA.

Sponsors

Canadian Stroke Consortium, Canadian Stroke Network, and Hoffman-La Roche Canada Ltd.