Clinical Trials

With stroke, timing is critical.  Tissue plasminogen activator (t-PA), 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 two to three 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.

Participation in research studies is optional.  For more information on these studies, call 202- 877-3154. 

Acute Stroke Clinical Trials

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 is 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 are conducting an MRI sub-study to determine whether this combination leads to quicker or more complete reperfusion of the ischemic brain. The NIH Stroke Program at MedStar Washington Hospital Center will begin recruiting patients for this trial this year.

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.

Secondary Stroke Prevention Clinical Trials

SAMMPRIS:  Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis

This NIH-funded trial investigates 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 is one of sixty medical centers participating in the study.

To learn more about the SAMMPRIS trial, click here.

Observational Studies

NIH Natural History of Stroke Study

The purpose of this study is to establish a registry of patients with stroke, including their clinical, laboratory and brain imaging information, to contribute to our knowledge and understanding of stroke as well as to serve as a basis for developing future studies.

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 is 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.

Completed Trials

CATALIST: Combination Anti-platelet and Anti-coagulation Treatment After Lysis of Ischemic Stroke Trial  

This trial evaluates 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 Inohep ®, to evaluate their combined effectiveness in restoring blood flow to the brain.

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.

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.