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

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)