Clinical Trials- Quick Summary

ACUTE TRIALS:

ASPIRE: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and AF.
Aspire Recruitment Video
Coordinator – MaryLiz

CAPTIVA: To determine if low-dose rivaroxban (2.5 mg BID), ticagrelor, or clopidogrel on top of standard aspirin therapy is safe and effective for prevention of recurrent vascular events in patients with 70-99% intracranial stenosis.

Coordinator – Nichole

DISCOVERY: This is a prospective, multi-center, observational, nested-cohort study. A total of 8,000 patients hospitalized at the DISCOVERY clinical sites with acute-onset AIS, ICH or aSAH and no history of dementia will be enrolled. All participants will undergo baseline screening for evidence of pre-stroke dementia. Those who pass baseline screening will complete a blood draw and a series of cognitive and functional assessments at baseline. In addition, some participants will also undergo brain MRI scanning, comprehensive cognitive assessment batteries and longitudinal blood collection.
Coordinator: Kaylin and Lexy

IMPERATIVE: To determine the safety and efficacy of the Zoom catheter reperfusion system for thrombectomy in stroke due to LVO within 8 hours. Single-arm trial with all enrolled patients receiving thrombectomy with the device.
Coordinator – Nichole

MOST: primary objective of the MOST trial is to determine if argatroban or eptifibatide results in improved 90-day modified Rankin scores (mRS) as compared with placebo in AIS patients treated with 0.9mg/kg IV rt-PA within three hours of symptom onset. Patients may also receive endovascular thrombectomy per usual care.
Coordinator – Nichole

OCEANIC –

PRESTA – A double-blind, randomized-controlled, phase 2 clinical trial of amantadine (100 mg twice daily or 100 mg once daily if 65 or older) versus placebo for promoting recovery in patients with ischemic or hemorrhagic stroke. Over 1 year at 3 sites, 60 patients will be enrolled. Subjects will be followed for 3 months to establish feasibility and tolerability. We aim to test the hypothesis that this medication is tolerable for post-stroke patients. We also hypothesize it will increase patient’s subjective sense of improvement. In addition, we plan to assess objective measures of improvement on various validated motor, cognitive, and mood scales. This trial addresses an important unmet therapeutic need.
Coordinator – Nichole

RESCUE– To evaluate the safety and efficacy of RNS60 (saline + O2 nanoparticles) in patients undergoing EVT. Patient are randomized to a 48-hour infusion of RNS60 vs placebo, and the infusion must be initiated before the completion of EVT (i.e. arterial access closure). A research MRI is to be performed <2 hours post-EVT, so early coordination with MRI and ICU nursing is needed.

SATURN: To determine the effects of continuation vs. discontinuation of statins on the risk of ICH recurrence during 24 months of follow-up in patients presenting with a spontaneous lobar lCH while taking a statin drug. Specifically, we wish to determine the effects of discontinuing vs. continuing statins on the risk of recurrent symptomatic ICH. We hypothesize that discontinuation of statins in patients with lobar ICH is likely associated with reduced risk of ICH recurrence.
Saturn Recruitment Video
Coordinator – MaryLiz

SLEEPSMART: The primary goals of this study are to determine whether treatment of OSA with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who
experienced an ischemic stroke.
Coordinator – Nichole

NON ACUTE TRIALS:

CREST-2: Carotid revascularization and medical management for asymptomatic carotid stenosis, patient must be greater than 35 with stenosis >70% by catheter angiography or US with >70% stenosis plus CTA/MRA >70% stenosis, end diastolic velocity >100 or internal carotid/common carotid artery peak systolic velocity ratio >4, no medical history of stroke or TIA ipsilateral to the stenosis in last 180 days, Rankin scale of 0 or 1
Coordinator – Nichole

CREST-H: to assess cognitive outcomes in a subset of CREST-2 patients with cerebral hypoperfusion and cognitive impairment, comparing those who get revascularized versus those who get intensive medical management alone
Coordinator – Nichole

ENRICH: Edoxaban compared with non-anticoagulant medical therapy (no antithrombotic therapy or antiplatelet monotherapy) for stroke prevention in high-risk AF (CHA2DS2-VASc score ≥2) patients and previous intracranial hemorrhage (includes: intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage and subdural hematoma). Participants will be randomly assigned to receive edoxaban 60/30 mg daily or to non-anticoagulant medical therapy (no antithrombotic therapy or antiplatelet monotherapy).
Coordinator – Nichole

REDUCE: To compare the effect of spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens on 3-month change in home systolic blood pressure (BP) in intracerebral hemorrhage (ICH) survivors.
Coordinator – MaryLiz

TRAINS: Subjects with cognitive impairment after stroke will undergo neuropsychological testing before and after receiving 5 semi-consecutive daily sessions of real or sham tDCS paired with cognitive therapy. Subjects will have experienced a stroke within 3 months of enrollment and will be undergoing inpatient rehabilitation at Penn Institute for Rehabilitation Medicine. Neuropsychological testing will be repeated immediately after completion of and 3 months following completion of treatment.
Coordinator –

INVESTIGATOR INITIATED TRIALS:

COMETS: DCS-based intraprocedural monitoring during ICA or M1 thrombectomy, measuring cerebral blood flow before and after thrombo
Coordinator: Sarah

DISCOVER: TCDs in older patients who received 7T MRI to look for R to L shunt & impaired cerebral vasoreactivity
Coordinator: Steph

DOMINO: Anterior circulation unilateral stroke within 72 hours- Study measuring the effect of inhaled nitric oxide on cerebral blood flow. Cannot have heart failure with severely reduced EF.
Coordinator: Steph

SERIAL MRI IN MINOR LVO: This is a prospective observational study aimed at quantifying and predicting the evolution of stroke in patients with LVO and low NIHSS (<6) being treated with medical therapy. Current imaging techniques are ineffective at predicting which patients with deteriorate and require rescue thrombectomy. Here, we will use short interval serial MRI (baseline MRI, +2 hour MRI) to quantify changes in tissue physiology that may predict tissue outcome and clinical outcome.
Coordinator: Sarah

SLAM: Patients with ischemic stroke with unilateral weakness, NIHSS >1 (including limb weakness), Control patients include: TIA with negative MRI and normal exam OR EMU patients with normal MRI and exam
Coordinator: Steph

THORNHILL STUDY: Moderate or severe MCA stenosis, measuring CVR in the setting of MCA stenosis, one time MRI Study (MRI will be done as outpatient)
Coordinator: Steph

CH in LVAD: TCD-based study to assess cerebral autoregulation and cerebral vasoreactivity before and after implantation of LVAD (pts on Cardiothoracic Surgery service, recruited by HF/Cardiology)
Coordinator: Sarah

CATCH (CGRP Antibody Therapy and Cerebral Hemodynamics): TCD-based study to assess cerebral autoregulation and cerebral vasoreactivity before and after initiation of CGRP monoclonal antibody therapies (OUTPT, recruited by Headache Clinic)
Coordinator: Sarah

Optical Biomarkers of Neurodegeneration in Chronic Cerebrovascular Disease (CVD): Correlating optically measured (DCS) cerebral hemodynamics (CA/CVR) with neurodegenerative changes on MRI for chronic carotid occlusive disease and small vessel ischemic disease.
Coordinator: Sarah

ACUTE TRIALS:

NON ACUTE TRIALS:

INVESTIGATOR INITIATED TRIALS:

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