Translating Clinical Research into Improved Stroke Patient Care
Clinical research at University Hospitals Neurological Institute’s Comprehensive Stroke Center in Cleveland, Ohio, is aimed at quickly translating basic science directly into improved patient care. Care at the Comprehensive Stroke Center is always shaped by the most innovative medical and surgical therapies because our experts continuously engage in research. Our affiliation with Case Western Reserve University School of Medicine allows basic science research to be quickly translated to findings that will improve patient care. Over the past several years, the Comprehensive Stroke Center has secured over $2 million in clinical research funding, the majority of it coming from the National Institutes of Health (NIH).
Understanding Clinical Trials
Clinical trials are research studies that involve the participation of human volunteers. The purpose of a clinical trial is to test the safety and effectiveness of new ways to diagnose, prevent and treat a medical problem, such as disease, illness or injury.
Being part of a clinical trial can be a chance for patients to receive new or additional treatment. While research may not always have a direct benefit to the participant, clinical trials can help scientists and doctors to learn and understand the better ways to help treat their patients and patients in the future.
Current Clinical Trials
StrokeNet is a new way of operating and conducting collaborative clinical National Institutes of Health (NIH) trials across the country. Cleveland has been chosen as a Regional Coordinating Center, which is comprised of the major health care institutions in the regions to conduct NIH stroke and neurology research. What makes this unique is that all institutions and the corresponding satellite hospitals will operate and conduct clinical research trials under one financial budget and contract and utilize one central Institutional Review Board (IRB). This will allow for us to maximize efficiencies in the development, promotion and conduct of multisite exploratory phase I, II and confirmatory phase III clinical trials in stroke prevention, treatment and recovery that are funded by NIH.
ARCADIA Study for cryptogenic stroke patients
We are currently enrolling in the ARCADIA study (“AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke”). ARCADIA is a clinical trial in search of better ways to prevent new strokes after occurrence of cryptogenic strokes. The trial compares apixaban, a blood thinner, to aspirin. Participants are patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. The information learned from this study may help determine the best treatment for patients with atrial cardiopathy who have had a stroke.
You may qualify if:
- You are 45 years or older
- You had a clinical diagnosis of stroke less than 120 days ago
- You had a stroke of undetermined source, or a cryptogenic stroke
BMS CV010031 for patients with ischemic stroke
A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Response-Adaptive Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA). This trial enrolls patients who are admitted to the hospital in an emergency situation.
CREST-2 & CREST-2 Registry
This study is actually two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will focus on carotid repair with carotid endarterectomy and the other will focus on carotid stenting. Aggressive medical management to control vascular risk factors will be uniform for all the treatment groups and will be centrally directed.
Please contact Carla Kinder, RN at 216-844-2988 if you would like more information on this study.
Sleep SMART Study for stroke patients with sleep apnea
We will soon be recruiting for Sleep SMART: Sleep for Stroke Management and Recovery Trial. This is a study being done to determine if treatment of obstructive sleep apnea with positive airway pressure after ischemic stroke or TIA reduced recurrent stroke, acute coronary syndrome, and death within six months of the initial stroke. It is also testing whether treatment of obstructive sleep apnea shortly after the ischemic stroke improves stroke recovery within three months. Automatically-adjusting positive airway pressure, aCPAP, will be tested against “usual care” for stroke patients with obstructive sleep apnea. About 3,000 patients will be enrolled in this study at 110 centers. Patients who meet criteria and consent to the study will be enrolled for six months.
You may qualify if:
- You are over 18 and have had a stroke or TIA within 14 days
- You were able to perform all basic activities of daily living prior to your stroke
- You are not currently using positive airway pressure or have not within one month of stroke
Some stroke trials that we conduct at University Hospitals enroll patients who are in the acute stage of their disease or injury. This means that patients are enrolled while they are in the emergency room, intensive care unit, or operating room. You can read about some of these trials below and at clinicaltrials.gov. For any questions about our current stroke studies, please contact Mary Andrews or Natalie Abraham
CHARM Study: Glibenclamide for large hemispheric infarction analyzing mRS and mortality
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction
Oral Factor XIa Inhibitor for the Prevention of New Ischemic Stroke in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)
The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention. The safety of this treatment will also be studied.