Clinical Trials- Quick Summary

ACUTE TRIALS:

ARCADIA: ESUS, age >45, signs of atriopathy (p wave terminal force >5000, BNP >250, or LA size index on TTE >3, within 3 to 180 days from stroke onset, randomized to aspirin versus apixaban
CoordinatorDevin

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
CoordinatorMaryLiz

AXIOMATIC/BMS: Phase 2, double blind study of BMS-986177 (oral factor XIa Inhibitor) for stroke prevention. Factor XIa inhibition has the potential to reduce thrombin generation enough to prevent vascular occlusion and embolism without impairing hemostasis. Patients age ≥40, w/in 48 hrs of symptom onset of stroke/TIA,  Stroke: ischemic, nonlacunar, NIHSS<7, pre-stroke mRS<3, TIA: neuro deficit, no infarct on MRI, ABCD2 >6 or motor symptoms;
CoordinatorDevin

CHARM: Study to evaluate the efficacy and safety of intravenous glibenclamide for severe cerebral edema following large hemispheric infarction, large MCA strokes (defined as 80 to 300 cm^3 on MRI or CTP or an ASPECTS score of 1 to 5), NIHSS >10, study treatment infusion within 10 hours of symptom onset or last known normal
CoordinatorDevin

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: Ann

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.
CoordinatorNichole

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
CoordinatorMaryLiz

SELECT-2: Thrombectomy vs medical management in LVOs in the anterior circulation (MCA M1 and ICA); patients with large core infarct on EITHER CT (ASPECTS 3-5) or CTP (rCBF <30%, ≥50cc)
CoordinatorNichole

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.
CoordinatorNichole

TIMELESS: Study to evaluate the efficacy and safety of tenecteplase vs placebo in AIS who present in the 4.5-24hr time window with ICA/MCA: M1/M2 occlusion.  Ages >18, prestroke mRS<2, NIHSS >5
CoordinatorNichole

NON ACUTE TRIALS:

ARCADIA: ESUS, age >45, signs of atriopathy (p wave terminal force >5000, BNP >250, or LA size index on TTE >3, within 3 to 180 days from stroke onset, randomized to aspirin versus apixaban
CoordinatorDevin

ARCADIA CSI: An ancillary study in that assesses cognitive function and silent infarcts in a subset of the ARCADIA population. The scientific premise is that silent brain infarcts are an important cause of post-stroke cognitive decline and that anticoagulation with apixaban (compared to aspirin) will reduce both silent infarcts and the rate of cognitive decline in patients with stroke of unknown cause and atrial cardiopathy.
CoordinatorDevin

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
CoordinatorMaryLiz

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
CoordinatorNichole

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
CoordinatorNichole

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).
CoordinatorNichole

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.
CoordinatorMaryLiz

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

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

RECAST: (Regional Evaluation of Cerebral Autoregulation in Stroke) Transcranial Doppler study measuring all 6 major cerebral arteries to assess autoregulatory function within 72 hours of stroke. Stroke has to be in only one vascular territory.
Coordinator: Sarah

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