Sentara Virginia Beach General Hospital is the only clinical trial site in Virginia to participate in a landmark Stroke treatment trial called "SAINT II," Stroke Acute Ischemic NXY Treatment. There are only 150 trial sited for this study across the United States, Canada and South America.
The phase three, randomized, double-blinded study is designed to test the investigational drug Cerovive, developed by AstraZeneca, trial sponsor, and licensed by Renovis, Inc. In earlier clinical trials, Cerovive has shown to improve disability in patients who have experienced stokes resulting from a clot.
"We couldn't be happier to play a lead role in this important investigational study," said Les Donahue, FACHE, Administrator, Sentara Virginia Beach General Hospital. "We are hopeful that SAINT II study will help to improve stroke treatment, care and outcomes."
The SAINT II trial is attempting to determine in Cerovive will improve recovery from an acute ischemic stroke. The study is designed to look at both overall recovery and recovery of motor function, for example, muscle strength and coordination.
"Every minute counts in terms of stroke treatment," explained Sidney Mallenbaum, MD, Medical Director, Sentara Virginia Beach General Hospital Stroke Service, who has done clinical research at the hospital for 10 years and is spearheading SAINT II participation here.
The only drug currently approved to treat Stroke is called Activase, or tPA, which breaks up blood clots, the cause of most strokes. But tPA must be given within three hours of a stroke in order to be effective, and most people do not get to a hospital that quickly.
In addition, before tPA is given, a CAT scan is needed to make sure the stroke was indeed caused by a clot and not by the bursting of a blood vessel, because the drug would make those strokes, known as hemorrhagic, worse.
Overall, the trial plans to include more than 1,500 subjects at the 150 sites. The anticipated completion of the trial which got underway in May 2003 is September 2005.
"We've done very well here with enrollment and we continue to actively recruit patients," said Mallenbaum. "We have neurologists on call 24/7 to the emergency department. Patients coming in are immediately assessed and if theyre a candidate for tPA, well give them that. If they also qualify for the SAINT II trial, well present that care option, too."
In order to qualify for the trial, patients must be at least 18-years-old and experiencing acute ischemic stroke with limb weakness with the onset of symptoms occurring within 6 hours. They must have had full functional independence prior to the present stroke.
Conditions which would eliminate a patient from trial participation include: Unconsciousness, severe illness with life expectancy less than 6 months, known severe kidney disorder; current or known alcohol or drug dependence; pregnant or breast feeding; participation in a previous clinical study within 30 days.
The SAINT II is a "double blinded, placebo study," which means that patients who participate have a 50% chance of being given the drug and a 50% chance of receiving a placebo. Neither the doctor administering the drug nor the patient knows which was received. This helps eliminate any chance for bias.
Stroke is an acute medical condition involving the death of brain tissue caused by blockage or rupture of the blood vessels leading to or within the brain. There are two major types of strokes: ischemic strokes account for about 85% of all strokes and caused by a blockage; hemorrhagic strokes account for 15% of all strokes and are caused by the sudden rupture or bursting of an artery.
According to the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics, stroke is the nations number 3 cause of death and a leading cause of serious, long-term disability. Every 45 seconds someone in America has a stroke. About 700,000 Americans will suffer a stroke this year and 168,000 of them will die.
Stroke is an emergency, and just as serious as a heart attack. If you experience symptoms of stroke, seek medical attention immediately. Call 911 getting help quickly can save your life and is critical to saying your brain function.
Symptoms of stroke may be sensory or motor in nature. They may include:
-Weak, numb or paralyzed feeling in face, arm or leg, especially on one side of body.
-Sudden blurry vision or loss of vision in one or both eyes.
-Slurred speech, inability to speak and/or inability to understand simple statements.
-Loss of balance or coordination.
-Vomiting or severe nausea.
-Sudden severe headache.
Sentara Virginia Beach General Hospital, located on First Colonial Road, offers comprehensive inpatient and outpatient services for the diagnosis and management of disorders of the nervous system including head and spine trauma, headaches, stroke, epilepsy, Parkinsons disease, multiple sclerosis, dementia, brain tumors and aneurysms.