News Release 

Lower dose of newer clot-buster may be appropriate for some stroke patients

American Stroke Association International Stroke Conference -- Late breaking science news release

American Heart Association

LOS ANGELES, Feb. 20, 2020 -- New research confirms that the lower 0.25mg/kg dose of the clot-busting agent tenecteplase is appropriate for eligible stroke patients and can reduce the need for mechanical clot removal, according to late breaking science presented today at the American Stroke Association's International Stroke Conference 2020. The conference, Feb. 19-21 in Los Angeles, is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

The clot-busting medication alteplase was approved by the U.S. Food and Drug Administration (FDA) 25 years ago for treating clot-caused stroke (ischemic stroke) within 3 hours of symptom onset and AHA guidelines recommend alteplase up to 4.5 hours after stroke onset. Alteplase is administered as an IV drip over an hour. Alternatively, tenecteplase, a genetically modified variant of alteplase, is more convenient because it is administered as a single injection directly into the vein and restored blood flow to the brain better than alteplase in a previous trial. Two different doses of tenecteplase have been used in previous trials, and AHA guidelines include recommendations for both doses. Tenecteplase use for ischemic stroke is currently not approved by the FDA.

Researchers say that, in addition, tenecteplase may be especially beneficial for patients who need to be transferred from the hospital where they initially present to a specialized stroke center for mechanical clot removal treatment- also known as a endovascular thrombectomy, a minimally-invasive procedure in which a small tube is inserted into the arteries of the brain to remove the clot causing the stroke.

Researchers investigated whether a dose of 0.25mg/kg or 0.40mg/kg of tenecteplase prior to mechanical clot removal is optimal for stroke patients.

Three hundred ischemic stroke patients with large vessel occlusion within 4.5 hours of onset were randomized to the two doses of tenecteplase. Researchers found:

the clot was largely dissolved prior to mechanical removal in 19.3% of patients with both groups;

there were no differences in functional outcome; and

symptomatic intracranial hemorrhage occurred in numerically fewer patients treated with the smaller dose (1.3%) compared to the larger dose (4.7%), although the difference was largely due to thrombectomy-related wire perforations.

"The two doses behaved very similarly overall, and there was no advantage to increasing the dose beyond 0.25mg/kg in this study," said Bruce Campbell, M.B.B.S., B.Med.Sc., Ph.D., head of stroke at the Royal Melbourne Hospital and professorial fellow at the University of Melbourne in Parkville, Australia. "These results provide reassurance that there is a window of safety if the weight-based dose is inadvertently overestimated."

"In addition, about 34% of patients treated in rural centers had substantially improved blood flow by the time they arrived at a hospital capable of performing mechanical clot removal," Campbell said. "This treatment could be particularly important for them."

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Study co-authors and disclosures are available in the abstract. The study was funded by the Australian National Health and Medical Research Council, and the National Heart Foundation, Australia.

Additional Resources:

VIDEO Perspective from Mitchell S. V. Elkind, M.D., M.S., FAHA, FAAN, president elect of the American Heart Association, may be downloaded on the right column of the release link along with any additional, available multimedia. https://newsroom.heart.org/news/lower-dose-of-newer-clot-buster-may-be-appropriate-for-some-stroke-patients?preview=1e1917a15f8413ef87588693bab46cc3

Ischemic Stroke Treatment

2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke

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Statements and conclusions of study authors that are presented at American Stroke Association scientific meetings are solely those of the study authors and do not necessarily reflect Association policy or position. The Association makes no representation or warranty as to their accuracy or reliability. The Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at https://www.heart.org/en/about-us/aha-financial-information.

The American Stroke Association's International Stroke Conference (ISC) is the world's premier meeting dedicated to the science of stroke and brain health. ISC 2020 will be held February 19-21 at the Los Angeles Convention Center in California. The 2 ½-day conference features more than 1,600 compelling scientific presentations in 21 categories that emphasize basic, clinical and translational science for health care professionals and researchers. These science and other clinical presentations will provide attendees with a better understanding of stroke and brain health to help improve prevention, treatment and outcomes for the more than 800,000 Americans who have a stroke each year. Stroke is the fifth leading cause of death and a leading cause of serious, long-term disability in the U.S. Worldwide, cerebrovascular accidents (stroke) are the second leading cause of death and the third leading cause of disability, according to the World Health Organization. Engage in the International Stroke Conference on social media via #ISC20.

About the American Stroke Association

The American Stroke Association is a relentless force for a world with fewer strokes and longer, healthier lives. We team with millions of volunteers and donors to ensure equitable health and stroke care in all communities. We work to prevent, treat and beat stroke by funding innovative research, fighting for the public's health, and providing lifesaving resources. The Dallas-based association was created in 1998 as a division of the American Heart Association. To learn more or to get involved, call 1-888-4STROKE or visit strokeassociation.org. Follow us on Facebook and Twitter.

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