Enrollment in NIH Study Concludes Early Due to Signficant Early Findings
Norfolk, VA (September 7. 2011) – Investigators with Sentara Neurosciences Institute and two local patients will continue to participate in a national stroke study even though new enrollment in the study was stopped ahead of schedule.
The study set out to help doctors understand how to prevent a damaging second stroke in high-risk patients.
The study was designed to compare treatment in two groups of stroke patients at high risk of having a damaging second stroke. Half of the patients in the study received aggressive medical management including efforts to quickly control high blood pressure and high cholesterol, combined with the use of blood thinning drugs. The other study participants received aggressive medical management and a stent to unclog very narrow vessels in the brain.
Early findings revealed the unexpected. Investigators thought it likely they’d see better results in patients who received the stents (tiny spring-like devices) used to prop open narrow and clogged arteries in the brain. When compared to the results of patients who only received aggressive medical management, those who received the stents faired far worse.
It is not uncommon for enrollment in studies to be stopped before time when early findings reveal significant variations in outcomes between the two study groups.
“Even when results are not what we’d hoped, having answers that challenge conventional thinking does improve care. Early findings like these give us reason to ask more questions that could lead to better treatments for stroke in the future,” says John Agola, MD, interventional neuroradiologist who practices at Sentara Norfolk General Hospital.
“Clinical research allows Sentara Neurosciences Institute to be part of something bigger than any one institution. We’re honored to be part of this and other studies that help reveal the best possible treatment for patients,” says Richard Zweifler, MD Sentara Chief of Neurology.
Aggressive medical management offers new hope for high risk stroke patients and those treatment regimens will likely be considered more for high-risk patients as a result of this study.
Read the full news release from the National Institutes of Health.
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