With stroke, timing is critical. Tissue plasminogen activator (tPA), the only FDA-approved clot-dissolving drug for acute stroke, must be administered within three hours of stroke onset. While this treatment option is very effective, only five percent of patients nationwide receive t-PA because of the small window of opportunity.
The stroke team at the Hospital Center is involved in several studies, including ones that extend the treatment window beyond three hours. As such, patients have access to the latest treatment options under the close supervision of experienced and highly qualified physicians and researchers.
MedStar Washington Hospital Center is a leader with its NIH-funded stroke clinical research programs:
Participation in research studies is optional. For more information on these studies, call 202-877-3154.
Randomized trial of endovascular therapy vs. medical management in the extended time window (6-16h) in acute stroke patients with anterior large vessel occlusion and
For more information: https://clinicaltrials.gov/ct2/show/NCT02586415
Randomized trial of treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80-130 mg/dL)
For more information: https://clinicaltrials.gov/ct2/show/NCT01369069
Randomized trial of carotid intervention and aggressive medical management in patients with asymptomatic high grade carotid stenosis
For more information: https://clinicaltrials.gov/ct2/show/NCT02089217
NIH Natural History of Stroke Study
The purpose of this study is to learn more about stroke and obtain information that may serve as the basis for future investigations. It will 1) establish a registry of patients with cerebrovascular disease (stroke); 2) characterize the natural history of acute stroke and transient ischemic attacks (TIA) an interruption of blood flow to the brain that causes stroke symptoms for a short period of time); and 3) evaluate the data to generate ideas for future studies.
Patients 18 years of age or older with suspected acute stroke or TIA may be eligible for this study. Subjects will be recruited from patients who present with stroke at the emergency department or while in the hospital.
The study will gather data collected from diagnostic and laboratory tests the patient undergoes as part of standard medical care, including findings of medical and neurological examinations and other tests. In addition, studies will be done for research purposes only to gather data about stroke and TIA. These may include the following:
Patients may be asked to return to the hospital for follow-up testing in 1, 3, and/or 12 months, when some of these tests may be repeated to assess changes over time.
For more information about NIH Natural History of Stroke: https://clinicaltrials.gov/ct2/show/NCT00009243
MR WITNESS Stroke Trial
IV rt-PA is currently administered up to 4.5 hours from last known symptom onset. However, approximately 25 percent of ischemic stroke patients have unwitnessed strokes. 16-28 percent of stroke patients wake up with their symptoms. These patients are not eligible for thrombolytic treatment based on last known well time or because their symptom onset was beyond the thrombolytic time window.
The purpose of MR WITNESS is to determine if it is safe to extend intravenous thrombolytic treatment with the assistance of an MRI-based "witness" when no human witness of stroke onset is available. This will also allow the study of novel MRI profiles that are consistent with early stroke. This study has important implications for having the potential to expand the number of patients who are eligible for thrombolytic therapy.
For more information: https://clinicaltrials.gov/ct2/show/NCT01282242
Lesion Evolution of Stroke and Ischemia On Neuroimaging (LESION)
Part of a larger National Institute of Neurological Disorders and Stroke (NINDS) Natural History of Stroke clinical research protocol, LESION was an ongoing longitudinal study of patients using serial MRI scans. With more than one thousand patients enrolled, LESION has yielded novel imaging markers that define the speed and biological effectiveness of recanalization and reperfusion, early blood brain barrier injury associated with the risk of brain hemorrhage from tPA, and the change in volumes of infarct associated with clinical recovery. These newer markers being developed in LESION will be used to select and assess patients for Phase II trials of novel stroke therapies.
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke-Enhanced Regimen (CLEAR-ER Stroke Trial)
IV rt-PA (Activase®) became the first scientifically proven and FDA-approved therapy for acute ischemic stroke in 1996. Despite this advance, 50 percent of treated patients treated remain disabled at three months, and IV rt-PA alone opens only 30-40 percent of arteries one hour after stroke onset. New combination approaches to improve the speed and success of early arterial recanalization are necessary for acute stroke treatment. Combination drug therapies of Glycoprotein (GP) IIb/IIIa antagonists and fibrinolytics have been demonstrated to increase arterial recanalization in acute myocardial infarction without associated increased rates of intracerebral hemorrhage.
The purpose of CLEAR-ER was to determine if the combination of a GP IIb/IIIa antagonist called Eptifibatide (Integrilin®), and a lower dose of the fibrinolytic, rt-PA, is a safe and effective treatment for stroke patients treated within a three-hour window from symptom onset. We also conducting an MRI sub-study to determine whether this combination leads to quicker or more complete reperfusion of the ischemic brain.
For more information about CLEAR-ER: https://clinicaltrials.gov/ct2/show/NCT00894803
SAMMPRIS: Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis
This NIH-funded trial investigated whether intracranial stenting (using the Wingspan self-expanding stent) and intensive medical therapy is superior to intensive medical therapy alone for preventing recurrent stroke. This is a multi-center, randomized, phase III clinical trial. MedStar Washington Hospital Center was one of sixty medical centers participating in the study.
For more information about SAMMPRIS: https://clinicaltrials.gov/ct2/show/NCT00576693
MR RESCUE: Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy
The purpose of this study was to compare the effectiveness of treating acute ischemic stroke with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT) or magnetic resonance (MR) imaging.
For more information about MR RESCUE: https://clinicaltrials.gov/ct2/show/NCT00389467
ASPIRE: Acute Stroke Program of Interventions Addressing Racial and Ethnic Disparities
The purpose of this study was to increase treatment of acute stroke with tissue plasminogen activator (tPA) across the District of Columbia. This study, however, will not evaluate tPA as an intervention.
For more information about ASPIRE: https://clinicaltrials.gov/ct2/show/NCT00724555
And here: Study in D.C. hospitals identifies factors for disparity in stroke treatment for blacks (Washington Post)
And here: http://www.washingtonpost.com/national/health/study-blacks-suffering-strokes-often-call-friends-first-not-911/2011/05/04/AFYKXixF_story.html
PROTECT DC: Preventing Recurrence of Thrombembolic Events Through Coordinated Treatment in the District of Columbia
The purpose of this study was to refine and evaluate the Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention. PROTECT DC was a program consisting of in-hospital education coupled with community-based "stroke navigators" and was designed to reduce the rate of vascular events or death in a population of underserved individuals with stroke.
For more information about PROTECT DC: https://clinicaltrials.gov/ct2/show/NCT00703274
CATALIST: Combination Anti-platelet and Anti-coagulation Treatment After Lysis of Ischemic Stroke Trial
This trial evaluated the benefits of using select medications in addition to t-PA to improve outcomes. Moderately severe ischemic stroke patients who receive t-PA (those who access medical care within three hours of stroke onset) are treated with three additional medications, aspirin, Integrilin™ and Innohep ®, to evaluate their combined effectiveness in restoring blood flow to the brain.
For more information about CATALIST: https://clinicaltrials.gov/ct2/show/NCT00061373
ROSIE (ReoPro Retavase Reperfusion of Stroke Safety Study – Imaging Evaluation)
This trial was an open-label, dose-escalation study of intravenous reteplase in combination with a fixed dose of abciximab for the treatment of ischemic stroke 3-24 hours from onset. MRI was obtained prior to treatment to determine patient eligibility. The results have not yet been published.
For more information about ROSIE: https://clinicaltrials.gov/ct2/show/NCT00046293
PRoFESS – Prevention Regimen for Effectively Avoiding Second Strokes: A double-blind, active and placebo controlled study of Aggrenox® vs. Plavix®, with and without Micardis®
This multi-center trial compared the effectiveness and safety of particular drugs in the prevention of recurrent stroke. The results were published in the New England Journal of Medicine on September 18, 2008, and demonstrated that the risks of recurrent stroke or the composite risk of stroke, myocardial infarction or vascular death are similar with either extended-release dipyridamole plus aspirin (Aggrenox®) vs. clopidogrel (Plavix®) in 20,332 patients with non-cardioembolic ischemic stroke. It also found that initiation of blood pressure lowering with telmisartan (Micardis®) after a stroke, with a relatively short duration of therapy of 2.5 years, does not significantly lower the rate of stroke or other major vascular events compared to placebo.
For more information about PROFESS: https://clinicaltrials.gov/ct2/show/NCT00153062
FAST: Recombinant Factor VIIa in Acute Intracerebral Hemorrhage (FAST)
The purpose of this study was to evaluate the treatment of Recombinant Factor VIIa in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.
For more information about FAST: https://clinicaltrials.gov/ct2/show/study/NCT00127283