Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
Information source: ImaRx Therapeutics
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Ischemic Stroke
Intervention: perflutren lipid microsphere (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: ImaRx Therapeutics Official(s) and/or principal investigator(s):
Andrei Alexandrov, MD, Principal Investigator, Affiliation: University of Texas, Houston
Summary
The study is designed to examine the safety, tolerability, and activity of a combination of
microbubbles (perflutren lipid microsphere [DefinityŽ]) and continuous monitoring with 2 MHz
transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen
activator (tPA) treatment in subjects with acute ischemic stroke.
Clinical Details
Official title: Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of symptomatic intracranial hemorrhage
Secondary outcome: Complete recanalization of the occluded artery (TIBI 4-5)NIHSS score of 0-2 Favorable outcome (modified Rankin Scale or NIHSS 0-1)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS]
score > 4 points)
tPA eligible
Occlusion of the middle cerebral artery
Exclusion Criteria:
Right to left cardiac shunt
Uncontrolled hypertension
Absent temporal windows
Locations and Contacts
Additional Information
Related publications: Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moye LA, Hill MD, Wojner AW; CLOTBUST Investigators. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. N Engl J Med. 2004 Nov 18;351(21):2170-8.
Starting date: March 2005
Ending date: May 2006
Last updated: July 25, 2007
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