The University of Texas Health Science Center in Houston (UTHealth) is participating in an international phase III clinical trial that will be studying the role of ultrasound and anti-clot therapy in the management of acute ischemic strokes. The trial is referred to as Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke (CLOTBUST-ER).
Currently, intravenous tissue plasminogen activator (tPA) is the mainstay therapy for the management of ischemic stroke (caused by the blood clot obstructing the vessel lumen). UT Health researchers identified the ability of transcranial Doppler ultrasound energy in dissoluting the clot-causing ischemia in cerebral vessels. The results of the phase 2 study were reported in the renowned New England Journal of Medicine in 2004 by Andrei V. Alexandrov when he was serving at UT Health. The results of the phase II study indicated significant arterial recanalization (almost 38% with ultrasound and tPA) when compared to 13% recanalization with tPA alone. Currently, Alexandrov is the director of the Division of Cerebrovascular Disease at the University of Alabama at Birmingham and global principal investigator of CLOTBUST-ER.
Phase III Clinical Trial of CLOTBUST-ER:
Andrew Barreto, M.D., assistant professor of neurology at the UTHealth Medical School and the North American principal investigator for the trial commented:
“We hope this will be the definitive trial to see if the delivery of ultrasound in combination with tPA results in better outcomes than the use of tPA alone. We will be assessing if the treatment leads to less disability and more independence for stroke victims.”
In the trial, researchers will utilize UTHealth technology that has been licensed to Cerevast Therapeutics Inc. The technology requires an operator-independent head frame that is capable of delivering ultrasound waves via 16 individual probes. Cerevast Therapeutics’ device, ClotBust-ERTM, has been successfully used in an NIH-sponsored Phase II safety study. Researchers will be using a sham device for the placebo-controlled portion of the CLOTBUST-ER trial.
Looking for more information about the CLOTBUST ER clinical study? Click on the banner ad below to go to the CLOTBUST ER clinical trials information page at clinicaltrials.gov:
Barreto explained how a head frame made the delivery of ultrasound waves easier in these words:
The first safety study was done with a diagnostic handheld probe placed against the temple and medical personnel had to be trained to properly administer the ultrasound. Now with Cerevast’s device, the operator-independent head frame can be placed on the head with minimal training by any emergency room staff member.”
Enrollment of the first patient in the trial:
In addition, UT Medical School is the first institute to enroll a study participant in the trial – 75 year-old, Enrique Chapa of Houston. As part of the double blind, placebo-controlled clinical study, a total of 830 patients will be enrolled across 60 international centers throughout the world. Due to double blind nature of trail, so far nobody knows if Chapa is enrolled in the study group or the placebo group. His family voluntarily agreed for his enrollment after he collapsed on May 20th, 2013 at home. His wife Tommie Chapa shared the details of the incident:
“He was watching the Astros and when he went to stand up, he just fell in slow motion. He thought his ankle gave out on him but my son Richard noticed that he couldn’t move his right leg and thought he was having a stroke so we called 911.”
The study objectives and goals were explained to Chapa while he was admitted at the Memorial Hermann-Texas Medical Center by Hari Indupuru – the study’s research assistant. Chapa’s son Michael Chapa explained in these words:
“Hari told us what they would do. He explained that it would massage the area and help the medicine work faster. We thought that even if he didn’t get the ultrasound, if it’s something to help in the future, great, I’m all for it. You’ll do anything that will help your father get back healthy.”
Other study participants will be enrolled at Memorial Hermann Southwest Hospital, Memorial Hermann-Texas Medical Center, and Baptist Beaumont Hospital.
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