AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenic stroke. (ARCADIA)
[Funded by: NINDS]
Key Inclusion Criteria:
- Age ≥ 45 years.
- Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
- Modified Rankin Scale (MRS) score ≤ 4.
- Ability to be randomized within 3 to 120 days after stroke onset.
- ESUS, defined as all of the following:
- Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts. Patients with a clinical lacunar stroke syndrome and no infarct on imaging are excluded.
- Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator.
- No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis). Patent foramen ovale is not an exclusion. All patients must undergo electrocardiogram, transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent.
This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT03192215
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction (CHARM)
[Study Sponsor: Biogen]
The purpose of this study is to test the efficacy and safety of BIIB093 on patients for Severe Cerebral Edema following Large Hemispheric Infarction (Ischemic Stroke).
Key Inclusion Criteria:
- Patients 18-85 years of age inclusive.
- A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory
- A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions
- Screening National Institutes of Health Stroke Scale (NIHSS) >=10
- Study treatment infusion within 10 hours after time of symptom onset, if known, or the time last known normal
- For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI
This study is also on www.clinicaltrials.gov. Once you access this page, look for identifier: NCT02864953
For questions regarding the above studies, please contact:
Eddie Soto, CCRP
Research Specialist, Senior
University of Arizona, Health Sciences, Department of Neurology
1501 N. Campbell Avenue
Tucson, AZ 85724
Fax: (520) 626-4903