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For Release September 19, 2000

IMPROVED CLOT-BUSTING DRUG FOR STROKE
AVAILABLE IN COUNTYWIDE CLINICAL TRIAL

Lyden

Dr. Patrick Lyden is impressed with the recovery of stroke patient Randy
Grove, 43, who received TNK, a modified form of t-PA.

Tenecteplase (TNK), a stronger, more potent form of the clot-busting drug t-PA for stroke patients, is now available at several San Diego hospitals as part of a unique clinical trial under the direction of the UCSD Stroke Center. The new drug holds promise for fewer bleeding complications than currently occur with t-PA.

According to UCSD Stroke Center director Patrick Lyden, M.D., the trial makes TNK available to patients who arrive at hospital emergency rooms with significant stroke three hours
or less from symptom onset.

Only two U.S. cities are participating in the two-year TNK trial. San Diego will treat 50 patients while the University of Virginia Health System in Charlottesville will enroll 25 stroke patients. Patient eligibility will be determined with blood tests and CAT scans.

Participating San Diego hospitals include UCSD Medical Center in Hillcrest and UCSD Thornton Hospital in La Jolla, Sharp Memorial Hospital, Grossmont Hospital, Scripps Mercy Hospital, Scripps Memorial Hospitals in La Jolla and Encinitas, Tri-City Medical Center, and Pomerado Hospital.

Lyden Press Conference
 Patrick Lyden M.D. discusses the clinical trial with Susan Duerksen of the San Diego Union Tribune.

 

The establishment of the San Diego hospital stroke network was made possible by a three-year $250,000 clinical trial grant from the National Institutes of Health, and a $100,000 donation from Rancho Santa Fe benefactors Maurice and Charmaine Kaplan. The Kaplan donation funds two physicians, Thomas Hemmen, M.D. and Brett Meyer, M.D., who are building the countywide network of stroke-response hospitals and, with Lyden and Karen Rapp, R.N., coordinating participation in the clinical trial.

TNK is a modified version of t-PA, a drug approved in 1996 by the Food and Drug Administration for the treatment of ischemic stroke, which occurs when a blood clot interrupts blood supply to the brain. Genentech, the company that developed both t-PA and TNK, made the new drug easier and faster to deliver as a single intravenous treatment rather than the prolonged infusion ordinarily needed to give t-PA.

Additional modifications were intended to lessen bleeding that occurred in some patients who received t-PA. Although all thrombolytic (blood-clot dissolving) agents increase the risk of bleeding, TNK is 10 times more likely to bind with and dissolve blood clot fibrin (protein strands), rather than the normal fibrin that floats freely in the bloodstream. TNK's fibrin specificity was recently demonstrated in a multi-center trial with heart attack patients; fewer bleeding complications occurred in the TNK recipients as compared to those given t-PA.

“We hope that TNK cures stroke with fewer bleeding side effects, compared to t-PA,” Lyden says. “One of our recent cases suggests this may be the case.”

On August 19, real estate agent Kathleen Fornal experienced sudden slurring of speech and a drooping of the left side of her face. The Carlsbad resident was taken to UCSD Thornton Hospital where the UCSD Stroke Team noted numbness and weakness on the entire left side of her body. After receiving TNK, she experienced a complete reversal of her stroke symptoms and showed no signs of excessive bleeding, in spite of a history of uterine bleeding. Eleven days later, Fornal was back at work, showing homes to perspective buyers and planning for her daughter’s upcoming wedding.

before after
When she arrived at UCSD Thornton Hospital, 51-year-old Kathleen Fornal could barely lift her left arm. Her face drooped and her speech was slurred. After receiving TNK for her stroke, Mrs. Fornal completely recovered use of her left arm and leg, her normal speech, and her facial expression.

“It’s important to note that Mrs. Fornal sought treatment within the three-hour window of opportunity,” Lyden says. “Even with the success of clot-busting drugs such as TNK, the ability to cure stroke still requires fast action by individuals who experience such symptoms as sudden weakness, paralysis or numbness; difficulty speaking or slurred speech; loss of balance or coordination; trouble seeing in one or both eyes; and sudden severe headache.”

San Diego’s stroke treatment network was enhanced recently when the County’s Emergency Medical Services division adopted new standardized stroke screening guidelines. While at the scene or on route to the hospital, paramedics look for slurred speech, an uneven facial grimace, and/or one arm that drifts when the individual attempts to hold both out evenly. If stroke is suspected, paramedics warn the hospital in advance of arrival so that neurologists can be summoned more quickly and necessary blood and CAT tests arranged – all saving the precious minutes needed to make drug therapy more effective.

For more information on the TNK clinical trial, call the UCSD Stroke Center at (619) 543-7760.

According to the National Stroke Association:

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Media Contact: Sue Pondrom  spondrom@ucsd.edu   619/543-6163

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