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Sponsors and Collaborators: |
University of Zurich Swiss National Science Foundation |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00336596 |
The purpose of the present, randomized, controlled multicenter phase III trial is to investigate the safety and efficacy of continuous 1-hour insonation of occluded middle cerebral artery with 2 MHz TCCS in stroke patients treated with intravenous tissue plasminogen activator (t-PA) within 3 hours after symptom onset.
Condition | Intervention | Phase |
---|---|---|
Intracranial Embolism Thrombosis |
Procedure: transcranial ultrasound in patients treated with iv t-PA |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Transcranial Ultrasound Enhanced Thrombolysis (TRUST) |
Estimated Enrollment: | 400 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2009 |
Thrombolysis with intravenous(iv) tissue plasminogen activator (t-PA) is the only effective and approved therapy for acute ischemic stroke. The most frequent cause of ischemic stroke is thrombosis of the middle cerebral artery (MCA). Preliminary in vitro, animal and human studies suggest that ultrasound accelerates thrombolysis induced by t-PA, and recanalization of acute MCA occlusion due to thrombolysis is an independent predictor of good clinical outcome. Thus, insonation of an occluded MCA through the temporal bone in stroke patients who are treated with iv t-PA might enhance recanalization and improve clinical outcome. The present prospective, randomized, controlled multicenter pilot study will investigate the safety and efficacy of continuous 1-hour insonation of the occluded MCA with 2 MHz transcranial color duplex sonography in patients with ischemic stroke treated with iv t-PA within 3 hours after symptom onset. It is planned to randomize 400 patients in 6 Swiss centers during an enrolment period of 33 months with an individual follow up of 3 months. The study endpoints include safety and efficacy assessments. The primary safety endpoint is to determine the rate of symptomatic intracranial hemorrhage (ICH) in both treatment groups. The primary efficacy endpoint is to determine whether a good functional outcome (modified Rankin scale, mRs, score of 0-2) differs between both treatment groups. Secondary endpoints include (1) asymptomatic ICH occuring during or within the first 24-48 hours after t-PA infusion, (2) early clinical recovery by 10 or more National Institute of Health Stroke Scale (NIHSS) points or dramatic recovery (total NIHSS score of 3 or less) at 24-48 hours after t-PA infusion, (3) mean mRS score at 90 days after t-PA infusion, (4) death occuring during the study period, and (5) recanalization at 24-48 hours after t-PA infusion.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ralf W Baumgartner, MD | +41 1 255 56 86 | ralf.baumgartner@usz.ch |
Switzerland | |
University Hospital of Zurich, Department of Neurology | Recruiting |
Zurich, Switzerland, 8091 | |
Contact: Ralf W Baumgartner, MD +41 1 255 56 86 ralf.baumgartner@usz.ch | |
Contact: Dimitrios Georgiadis, MD dimitrios.georgiadis@usz.ch | |
Principal Investigator: Ralf W Baumgartner, MD | |
Principal Investigator: Dimitrios Georgiadis, MD | |
Sub-Investigator: Hakan Sarikaya, MD | |
Kantonsspital Aarau, Department of Neurology | Recruiting |
Aarau, Switzerland | |
Contact: Hansjörg Hungerbühler, MD +41 62 838 66 75 hansjoerg.hungerbuehler@ksa.ch | |
Principal Investigator: Hansjörg Hungerbühler, MD | |
University Hospital of Basel, Department of Neurology | Recruiting |
Basel, Switzerland | |
Contact: Stefan Engelter, MD +41 61 265 25 25 sengelter@uhbs.ch | |
Principal Investigator: Philippe Lyrer, MD | |
Principal Investigator: Stefan Engelter, MD | |
University Hospital of Lausanne, Department of Neurology | Recruiting |
Lausanne, Switzerland | |
Contact: Patrik Michel, MD +41 21 314 11 85 patrik.michel@chuv.hospvd.ch | |
Principal Investigator: Patrik Michel, MD | |
University Hospital of Geneva, Department of Neurology | Recruiting |
Geneva, Switzerland | |
Contact: Roman Sztajzel, MD +41 22 372 83 10 Roman.Sztajzel@hcuge.ch | |
Principal Investigator: Roman Sztajzel, MD | |
University hospital of Bern, Department of Neurology | Recruiting |
Bern, Switzerland | |
Contact: Marcel Arnold, MD +41 31 632 33 32 marcel.arnold@insel.ch | |
Principal Investigator: H.-P. Mattle, MD | |
Principal Investigator: Marcel Arnold, MD |
Study Chair: | Ralf W Baumgartner, MD | University Hospital of Zurich, Department of Neurology, Zurich, Switzerland |
Study ID Numbers: | E-031/2004 |
Study First Received: | June 13, 2006 |
Last Updated: | April 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00336596 |
Health Authority: | Switzerland: Swissmedic |
middle cerebral artery occlusion intracranial embolism and thrombosis ultrasound enhanced thrombolysis Intracranial embolism and thrombosis Patients receiving iv thrombolytic therapy (t-PA) |
Cerebral Infarction Stroke Vascular Diseases Tissue Plasminogen Activator Central Nervous System Diseases Cerebral Arterial Diseases Ischemia Intracranial Embolism Brain Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Intracranial Embolism and Thrombosis Thrombosis Thromboembolism Embolism and Thrombosis Infarction, Middle Cerebral Artery Embolism Brain Ischemia Brain Infarction Infarction |
Nervous System Diseases Cardiovascular Diseases |