Combined Lysis of Thrombus in Brain Ischemia with Transcranial Ultrasound and Systemic TPA [SPOTRIAS] "CLOTBUST Phase II"

Completed

Phase N/A Results

Trial Description

To determine complete recanalization, early clinical recovery rates, and safety of continuous monitoring in patients treated with 2 Mhz transcranial Doppler (TCD) used in conjuction with tissue plasminogen activator (tPA) in patients with acute ischemic stroke.

Interventions

Trial Design

Prospective, randomized, multi-center clinical trial.

Patient Involvement

All patients received a standard dose of tPA (0.9 mg/kg) with either 2 hours of TCD monitoring or placebo monitoring.

Outcomes

Type Measure Time Frame Safety Issue
Primary Complete recanalization within 2 hours, early or dramatic clinical recovery at 2 hours and 24 hours, intracerebral hemmorhage with clinical worsening.
Secondary Clinical recovery at 24 hours as measured by NIHSS; favorable outcome at three months as measured by modified Rankin; and mortality at three months.

Sponsors

A2207s, Genetech, Inc.