CLOTBUST-ER
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of the Combined Lysis of Thrombus With Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization (CLOTBUST-ER) in Acute Ischemic Stroke
Sponsor study identifier
interventional
675
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2010
Actual (reported)April 6, 2010
Actual (reported)May 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 2015
Actual (reported)April 2015
Actual (reported)Modified Rankin score ordinal shift analysis
The primary objective of this study is to compare clinical recovery rates (modified Rankin score ordinal shift analysis) at 3 months after stroke onset.
3 months
Symptomatic intracerebral hemorrhage
0-24 hours from treatment
A combined treatment with transcranial US and systemic tPA
Systemic tPA alone
* tPA per approved labeling administered over 60 minutes * Ultrasonic headframe with active insonation for 120 minutes
* tPA per approved labeling administered over 60 minutes * Ultrasonic headframe with sham (inactive) insonation for 120 minutes
Cerevast Therapeutics, Inc.
Redmond, Washington, 98052-2431, United States
Alexandrov AV, Kohrmann M, Soinne L, Tsivgoulis G, Barreto AD, Demchuk AM, Sharma VK, Mikulik R, Muir KW, Brandt G, Alleman J, Grotta JC, Levi CR, Molina CA, Saqqur M, Mavridis D, Psaltopoulou T, Vosko M, Fiebach JB, Mandava P, Kent TA, Alexandrov AW, Schellinger PD; CLOTBUST-ER Trial Investigators. Safety and efficacy of sonothrombolysis for acute ischaemic stroke: a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Neurol. 2019 Apr;18(4):338-347. doi: 10.1016/S1474-4422(19)30026-2.
Schellinger PD, Alexandrov AV, Barreto AD, Demchuk AM, Tsivgoulis G, Kohrmann M, Alleman J, Howard V, Howard G, Alexandrov AW, Brandt G, Molina CA; CLOTBUSTER Investigators. Combined lysis of thrombus with ultrasound and systemic tissue plasminogen activator for emergent revascularization in acute ischemic stroke (CLOTBUST-ER): design and methodology of a multinational phase 3 trial. Int J Stroke. 2015 Oct;10(7):1141-8. doi: 10.1111/ijs.12536. Epub 2015 Jun 29.
675 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2010
First Posted
April 6, 2010
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
April 7, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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