Clinical Trials- Quick Summary

Quick summary of trials:

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 120 days from stroke onset, randomized to aspirin versus apixaban

BAF312: study of BAF312 in hemorrhage to study efficacy, safety and tolerability.  BAF312 is a drug that could potentially limit brain inflammation after ICH and thereby improve outcomes for hemorrhage patients, Age 18 to 80 years, spontaneous, supratentorial intracerebral hemorrhage in deep brain structures with a volume of 10-30 ml, less than 24 hours from last known normal

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<5, pre-stroke mRS<3, TIA: neuro deficit, no infarct on MRI, ABCD2 >6 or motor symptoms; CanNOT have had more than 300mg of clopidogrel prior to randomization.

CELERY: Phase 2, double blind study of NBP to evaluate safety of the treatment in mild-moderate AIS. Age 18-85, inclusive, NIHSS 4-17 inclusive, LKN w/in 24hrs, cleared speech/swallow, prestroke mRS <1, 1st dose 4hrs after tPA(if given), QTcF (Fridericia) < males:450ms/ females: 470ms, AST/ALT< 1.5ULN, or bilirubin < 1.5 ULN. 30 days of drug, 60 days of follow-up.

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

MEDTRONIC STROKE AF: ischemic stroke due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days, 60 years or older or age 50-59 with one addition risk factor, excluded if already have afib or a permanent indication for anticoagulation

STRONG: aims to examine how certain genes and lifetime and ongoing stress may impact rehabilitation and recovery after stroke. The proposed studies will examine how genes interact with rehabilitation therapy and with stress to affect recovery after stroke. This study may provide insight into biological factors underlying this relationship, and so may help individualize rehabilitation care.

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

TIA Biomarker: Suspected TIA or minor stroke (NIHSS 4 or less), age 40 or older, blood draw within 72 hours of TIA/minor stroke onset, mimics are okay- you don’t have to be a TIA or stroke for sure, just enough to work up

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

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

PROWALKS: Goal of this study is to improve walking ability after stroke, age 21-85, >6 months post stroke, able to walk without assistance from a person

SELECT: Semaglutide effects on cardiovascular outcomes in people with overweight or obesity, age >45, BMI >27 and prior MI, prior stroke (ischemic or hemorrhagic), or PAD, must wait at least 60 days post stroke

INVESTIGATOR INITIATED TRIALS:

COMETS: ICA or M1 thrombectomy, measuring cerebral blood flow before and after thrombo

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

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.

iSAD: Internet-based CBT after stroke, 18 years or older, stroke within 6 months, regular access to the internet, symptoms of mild to moderately depressed mood, defined as a score of 5-19 on the PHQ-9 questionnaire

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

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)