Providence Sacred Heart Medical Center and Providence Medial Research Center have been selected as one of about 50 sites for a National Institutes of Health study to determine if aggressive treatment of stroke victims for high blood pressure and cholesterol-along with placing a stent to widen a narrowed artery in a patient's brain-can reduce their risk of having a second stroke.
"People who suffer an ischemic stroke, the most common kind of stroke, have a 30 percent to 50 percent chance of having another stroke," says Dr. Chris Zylak, a neurointerventional radiologist and the lead researcher for the study here. Drs. Zylak and Madeleine Geraghty, director of Sacred Heart's Primary Stroke Center, will treat study patients.
The best treatment for prevention of another stroke or TIA (transitory ischemic attack or mini stroke) in patients with narrowing of one of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting medications to prevent blood clots from forming in the narrowed vessel. There are a variety of medicines used for this purpose. These medications are usually taken for the rest of a patient's life.
The SAMMPRIS trial is a study funded by The National Institutes of Health (NIH). It is being done to determine whether intracranial stenting (a device inserted in a blood vessel in the brain) combined with intensive medical therapy is better than intensive medical therapy alone for preventing stroke or death in individuals who have had a stroke or TIA caused by a narrowing in one of the arteries in the brain.
The stenting procedure is a treatment that has been used successfully, together with anti-clotting medications, in patients with narrowing of the blood vessels of the heart and will now be studied in the blood vessels of the brain.
Recent research has also indicated a benefit in prevention of recurring stroke by Intensive Medical Therapy, which is defined as treating risk factors for stroke like high blood pressure, elevated LDL (low density lipids - the "bad" form of cholesterol) and diabetes. The purpose of this study is to compare the safety and effectiveness of either Intensive Medical Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks or death.
A previous NIH funded clinical trial showed that aspirin was as effective and safer than warfarin for preventing stroke in patients with intracranial stenosis, and that patients with 70%-99% intracranial stenosis (narrowing of a blood vessel in the brain) had a high risk of stroke <u>despite</u> antithrombotic therapy and usual management of vascular risk factors. The high risk of stroke in these patients suggests the need for alternative therapies such as intensive management of vascular risk factors and intracranial stenting.
Participants in the SAMMPRIS trial will be individuals who had a TIA or stroke within 30 days prior to enrollment and have "symptomatic stenosis" of a major intracranial artery.
The study will enroll patients over a 5 year period. Each participant will be involved in the study for a minimum of 1 year and a maximum of 3 years. Patients will be evaluated by study neurologists every 4 months to determine the occurrence of "endpoints" and by study internists who will manage the vascular risk factors of all study patients. Study "endpoints" are what researchers monitor to determine the effectiveness of a treatment. In this study, researchers are monitoring patients to see if they suffer a stroke or TIA, heart attack or death.
Fifty different medical centers in the United States are part of this study. Providence Sacred Heart Medical Center and Children's Hospital is on of these sites. Both the Clinical Coordinating Center and the Statistical Coordinating Center for the entire study are located at Emory University.