November 23, 2014
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Kent chosen for trial of new clot-busting stroke drug

According to the American Heart Association, someone suffers from a stroke every 45 seconds. On average, someone dies from a stroke every three minutes. The AHA cites strokes as the fourth leading cause of death in the United States and the leading cause of long-term disabilities.

The key to preventing such disabilities is dissolving the clot within the brain responsible for the stroke. Up to now, tissue plasminogen activator (TPA) has been the prescription administered to stroke victims. But TPA only works to dissolve a clot for up to three hours after the onset of a stroke.

TPA allots a very small window of time, and for those that suffer a stroke in the middle of the night or are unsure when the onset of the symptoms occurred, the timeframe may be insufficient.

A new drug, Demoteplase, has been studied in several trials and may benefit stroke victims up to nine hours after the onset of symptoms.

Kent Hospital has been chosen to participate in a clinical trial of the new drug.

“The purpose is to significantly limit disabilities,” said Kent Hospital neurologist Dr. S.M. Arshad Iqbal.

Most strokes are caused by a blockage of oxygen to the brain due to a blood clot. Demoteplase would dissolve the clot, restoring normal function.

Dr. Iqbal said initial studies of the drug show effectiveness in doing this after nine hours, but this clinical trial will enroll a much larger number of patients.

Kent is one of 80 hospitals worldwide chosen to participate in the clinical trial, and one of only 35 in the U.S. Lundbeck, the Norwegian pharmaceutical company that produces Demoteplase, is funding the study.

Sandra Colletta, CEO of Kent Hospital, said patients who undergo treatment with the trial drug must be eligible, which requires that they be beyond the three-hour time limit for TPA. Patients must also be willing to sign consent forms. Should they not be able to sign the forms themselves, consent will be deferred to family. Patients will not be compensated monetarily.

The trial will continue indefinitely until enough cases are documented to prove the efficacy or inefficacy of the drug.

Colletta said this could take some time, the goal being to test a certain number of patients across the 80 hospitals. This means that Kent may only end up testing a handful of patients, while other hospitals could administer the drug to many more.

“I’m very excited about this,” said Dr. Iqbal about the trial of Demoteplase. “There’s suddenly a much larger window of opportunity.”

Dr. Iqbal is hopeful that this treatment will prevent a larger number of permanent disabilities.

Despite the promise of the new treatment, Iqbal encourages people to seek medical help as soon as they believe they are experiencing the onset of a stroke.

“People still have to undergo testing to determine treatment,” he said, which can add critical time to the three-hour window of efficacy for TPA.

Symptoms of a stroke include abrupt loss of function (such as speech, sight and mobility) or sudden numbness in an area of the body.

“People experience numbness and think it will go away on its own,” said Dr. Iqbal. But if a stroke victim lets the symptom go, they may lose their ability to walk, speak or use a limb.

“The key is abrupt or sudden change,” said Dr. Iqbal, who said people should take note of any sudden changes to their function.

“People who have hypertension, diabetes, high cholesterol, risk of heart attack or previous strokes are most at risk,” he said.

“These symptoms are most prevalent above age 60.”

But that doesn’t mean that people under the age of 60 are exempt from having a stroke.

“Smokers of any age are at risk,” he said, “and young women who smoke and are on birth control.”

Despite his hopes for a successful trial, Iqbal is still mindful of the long way Demoteplase must go before FDA approval.

“This is a trial,” he said. “It doesn’t mean we have a [new] treatment.”


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