Current Clinical Trial at BIDMC Stroke Center
Acute Stroke Trials
Dose escalation study of desmoteplase in acute ischemic stroke (DEDAS)
“Only at the BIDMC - The Stroke Center at BIDMC is proud to be the only place in New England to participate in this trial”
Purpose: To assess the safety and efficacy of a novel intravenous thrombolytic agent, called desmoteplase(vampire bat plasminogen activator), in patients with acute ischemic stroke.
Design: Multicenter, international,double-blind, placebo-controlled, dose-escalating, randomized Phase I/II trial.
Inclusion Criteria: Patients between 18 and 85 years of age who present between 3 and 9 hours after onset of ischemic stroke symptoms and have no contraindication to undergo MRI or to intravenous thrombolysis.
Intervention: Patients will receive intravenous desmoteplase, given as a single bolus injection, or placebo (5:1 ratio).
Patient Involvement: Prospective participants will undergo a complete history and physical, diffusion- and perfusion-weighted MRI and MRA, laboratory tests, and other trial-related assessments at baseline in order to determine eligibility. Each patient will be followed for 3 months after stroke onset. Patients will undergo 2 further clinical assessments and 2 additional MRI during the 3-month trial period.
Diffusion-weighted imaging Evaluation For Understanding Stroke Evolution (DEFUSE)
“Only at the BIDMC - The Stroke Center at BIDMC is proud to be the only place in New England to participate in this trial”
Purpose: To investigate whether specific profiles on diffusion- and perfusion-weighted MRI predict a favorableclinical response to intravenous t-PA therapy administered between 3 and 6 hours after stroke onset.
Design: Multicenter, NIH-funded, open-label, pilot study.
Inclusion Criteria: Patients between 18-80 years of age with ischemic stroke who present within 3-6 hours of stroke onset. Patients must undergo both a CT and
diffusion/perfusion MRI and MRA before t-PA administration.
Intervention: Intravenous t-PA.
Patient Involvement: Participants will undergo a complete history and physical, diffusion- and perfusion-weighted MRI and MRA, laboratory tests, and other trial-related assessments at baseline in order to determine eligibility. Each patient will be followed for 3 months after stroke onset. Patients will undergo further clinical assessments and 2 additional MRIs during the 3-month trial period.
A Pilot Study to Evaluate the Safety and Efficacy of Desferoxamine in Stroke Patients (DFO IN STROKE)
Purpose: To investigate the safety and biological effects of the iron chelator, Desferoxamine, in patients with ischemic and hemorrhagic strokes
Design: This is an investigator initiated, single center, open-label pilot study. The study is supported by a research grant from the Harvard Center for Neurodegeneration and Repair.
Inclusion Criteria: Patients 50 yr of age or older, with confirmed diagnosis of stroke (ischemic or hemorrhagic) by CT or MRI, who present within 24 hours of stroke onset.
Intervention: Patients will receive one of 3 doses of deferoxamine, by IV/IM injections for 3 consecutive days.
Patient Involvement: Patients will undergo clinical assessments (NIHSS, mRS, MMSE) and will have blood drawn for assessments of iron measures and markers of oxidative stress during hospitalization. Patients will be seen once, as outpatients, on day 30-45.
Stroke Prevention Trials
Prevention Regimen For Effectively avoiding Second Strokes (PRoFESS)
Purpose : To compare the efficacy and safety of Aggrenox®(25 mg aspirin/200 mg extended-release dipyridamole) with clopidogrel + aspirin, and Micardis® (telmisartan) with placebo in preventing recurrent stroke.
Study Design : Randomised, parallel group, multi-national, double-blind, double dummy, placebo controlled study.
Inclusion Criteria : Males and females over 55 years of age who have had a stroke within 90 days.
Intervention(s): Aspirin + clopidogrel, Aggrenox®, or placebo + Micardis® or placebo.
Patient Involvement : 15,500 patients, wordwide, will be randomized into either active or placebo groups. Half of the active group participants will receive Aggrenox®and Micardis® (telmisartan), while the other half will receive Clopidogrel, Aspirin, and Micardis®. The placebo group will also be split, with half receiveing Aggrenox®and placebo, with the remainder receiving Clopidogrel, Aspirin, and Placebo.
Primary Outcome : Time to first recurrent stroke. Secondary Outcome(s) : Composite endpoint of vascular events (first non-fatal stroke, non-fatal MI, vascular death). Composite endpoint of other designated vascular events (time to first PE, retinal vascular accident that is not a retinal arterial occlusion, DVT, peripheral arterial occlusion, and stroke type).
Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment Trial (RESPECT)
Purpose: To investigate whether percutaneous PFO closure is better than or equivalent to current standard of care medical therapy in the prevention of recurrent symptomatic stroke.
Design: Multicenter, randomized,active control, blinded adjudicated outcome, clinical trial.
Inclusion Criteria: Patients aged 18-55 with patent foramen ovale who have had a cryptogenic stroke within the last 6 months.
Intervention: Medical therapy (aspirin, clopidogrel, aspirin combined with dipyridamole or clopidogrel, or warfarin) or PFO closure with the AMPLATZER PFO Occluder. Patient Involvement: Participants will undergo a complete history and physical by a
Cardiologist and a Neurologist, and transesophageal echocardiogram (TEE) at baseline and 6-month postintervention to assess for complete closure of the inter-atrial defect, recurrent strokes or cardiovascular adverse effects.
THE BIDMC COMPREHENSIVE STROKE CENTER
24 HOUR TRIALS HOTLINE(617)-667-7000; PAGE # 37828 [3STAT]
Stroke Trials Directory
http://www.strokecenter.org/trials
